Valsartan

Hypesthesia, Hypesthesia, Hypesthesia + 15 more

Treatment

12 FDA approvals

20 Active Studies for Valsartan

What is Valsartan

Valsartan

The Generic name of this drug

Treatment Summary

Valsartan is a medication used to treat high blood pressure, heart failure, and kidney damage caused by diabetes. It is part of the angiotensin II receptor blocker (ARB) family of drugs, which works by blocking the activity of a protein called angiotensin II. This protein causes blood vessels to narrow, leading to higher blood pressure. By blocking its activity, valsartan helps lower blood pressure and reduce the risk of heart attack and stroke. It is usually well tolerated and has a lower risk for side effects compared to other antihypertensive drugs. Valsartan was approved in 1996 in Europe

Diovan

is the brand name

image of different drug pills on a surface

Valsartan Overview & Background

Brand Name

Generic Name

First FDA Approval

How many FDA approvals?

Diovan

Valsartan

1996

621

Approved as Treatment by the FDA

Valsartan, also known as Diovan, is approved by the FDA for 12 uses such as Heart Failure and chronic heart failure with reduced ejection fraction (NYHA Class II-IV) .

Heart Failure

Used to treat Heart Failure in combination with Sacubitril

chronic heart failure with reduced ejection fraction (NYHA Class II-IV)

Used to treat chronic heart failure with reduced ejection fraction (NYHA Class II-IV) in combination with Sacubitril

Heart failure

Used to treat Heart Failure in combination with Sacubitril

Combined Modality Therapy

Used to treat patients for whom combination therapy is appropriate in combination with Hydrochlorothiazide

Moderate Essential Hypertension

Used to treat Moderate Essential Hypertension in combination with Hydrochlorothiazide

Heart Failure

Used to treat hospitalization due to cardiac failure in combination with Sacubitril

Systolic Left Ventricular Dysfunction

Used to treat Systolic Left Ventricular Dysfunction in combination with Sacubitril

High Blood Pressure

Used to treat Moderate Essential Hypertension in combination with Hydrochlorothiazide

Cardiovascular Mortality

Used to treat Cardiovascular Mortality in combination with Sacubitril

Hypesthesia

Used to treat chronic heart failure with reduced ejection fraction (NYHA Class II-IV) in combination with Sacubitril

Congestive Heart Failure

Used to treat Heart Failure in combination with Sacubitril

Ventricular Dysfunction, Left

Used to treat Systolic Left Ventricular Dysfunction in combination with Sacubitril

Effectiveness

How Valsartan Affects Patients

Valsartan helps to control blood pressure by blocking the effects of a hormone (angiotensin II). It usually takes an oral dose of 80mg to reduce blood pressure by around 80%. The use of valsartan can lead to a slight decrease in cholesterol, triglycerides, glucose, and uric acid. Low blood pressure can be a side effect of valsartan, especially in patients who are already low in salt or taking high doses of diuretics. People with heart failure may also experience low blood pressure when taking valsartan, but usually it is not severe. If low blood pressure does occur

How Valsartan works in the body

Valsartan is a drug that belongs to a family of medications called angiotensin II receptor blockers (ARBs). It works by blocking the receptor that angiotensin II binds to in order to control blood pressure and reduce inflammation. This helps to lower the amount of stress on the heart, improve cardiac function, and reduce the chances of a heart attack or stroke. Valsartan is used to treat high blood pressure, heart failure, and complications related to diabetes and kidney disease. It can also be used to slow the progression of kidney disease. Valsartan has a much higher affinity for the AT1 receptor

When to interrupt dosage

The prescribed measure of Valsartan is contingent upon the determined illness, such as initial treatment, Left Ventricular Failure, Unspecified and Combined Modality Therapy. The amount of dosage is contingent upon the method of delivery (e.g. Tablet - Oral or Tablet, film coated) featured in the table beneath.

Condition

Dosage

Administration

Hypesthesia

160.0 mg, 320.0 mg, , 80.0 mg, 40.0 mg, 1.6 mg, 3.2 mg, 26.0 mg, 51.0 mg, 103.0 mg, 4.0 mg/mL

Tablet, film coated, , Oral, Tablet, film coated - Oral, Tablet, Tablet - Oral, Capsule, Capsule - Oral, Solution - Oral, Solution

Hypesthesia

160.0 mg, 320.0 mg, , 80.0 mg, 40.0 mg, 1.6 mg, 3.2 mg, 26.0 mg, 51.0 mg, 103.0 mg, 4.0 mg/mL

Tablet, film coated, , Oral, Tablet, film coated - Oral, Tablet, Tablet - Oral, Capsule, Capsule - Oral, Solution - Oral, Solution

Hypesthesia

160.0 mg, 320.0 mg, , 80.0 mg, 40.0 mg, 1.6 mg, 3.2 mg, 26.0 mg, 51.0 mg, 103.0 mg, 4.0 mg/mL

Tablet, film coated, , Oral, Tablet, film coated - Oral, Tablet, Tablet - Oral, Capsule, Capsule - Oral, Solution - Oral, Solution

Hypesthesia

160.0 mg, 320.0 mg, , 80.0 mg, 40.0 mg, 1.6 mg, 3.2 mg, 26.0 mg, 51.0 mg, 103.0 mg, 4.0 mg/mL

Tablet, film coated, , Oral, Tablet, film coated - Oral, Tablet, Tablet - Oral, Capsule, Capsule - Oral, Solution - Oral, Solution

Diabetic Nephropathies

160.0 mg, 320.0 mg, , 80.0 mg, 40.0 mg, 1.6 mg, 3.2 mg, 26.0 mg, 51.0 mg, 103.0 mg, 4.0 mg/mL

Tablet, film coated, , Oral, Tablet, film coated - Oral, Tablet, Tablet - Oral, Capsule, Capsule - Oral, Solution - Oral, Solution

Congestive Heart Failure

160.0 mg, 320.0 mg, , 80.0 mg, 40.0 mg, 1.6 mg, 3.2 mg, 26.0 mg, 51.0 mg, 103.0 mg, 4.0 mg/mL

Tablet, film coated, , Oral, Tablet, film coated - Oral, Tablet, Tablet - Oral, Capsule, Capsule - Oral, Solution - Oral, Solution

Type 2 Diabetes

160.0 mg, 320.0 mg, , 80.0 mg, 40.0 mg, 1.6 mg, 3.2 mg, 26.0 mg, 51.0 mg, 103.0 mg, 4.0 mg/mL

Tablet, film coated, , Oral, Tablet, film coated - Oral, Tablet, Tablet - Oral, Capsule, Capsule - Oral, Solution - Oral, Solution

High Blood Pressure

160.0 mg, 320.0 mg, , 80.0 mg, 40.0 mg, 1.6 mg, 3.2 mg, 26.0 mg, 51.0 mg, 103.0 mg, 4.0 mg/mL

Tablet, film coated, , Oral, Tablet, film coated - Oral, Tablet, Tablet - Oral, Capsule, Capsule - Oral, Solution - Oral, Solution

Cardiovascular Mortality

160.0 mg, 320.0 mg, , 80.0 mg, 40.0 mg, 1.6 mg, 3.2 mg, 26.0 mg, 51.0 mg, 103.0 mg, 4.0 mg/mL

Tablet, film coated, , Oral, Tablet, film coated - Oral, Tablet, Tablet - Oral, Capsule, Capsule - Oral, Solution - Oral, Solution

Hypertensive disease

160.0 mg, 320.0 mg, , 80.0 mg, 40.0 mg, 1.6 mg, 3.2 mg, 26.0 mg, 51.0 mg, 103.0 mg, 4.0 mg/mL

Tablet, film coated, , Oral, Tablet, film coated - Oral, Tablet, Tablet - Oral, Capsule, Capsule - Oral, Solution - Oral, Solution

Combined Modality Therapy

160.0 mg, 320.0 mg, , 80.0 mg, 40.0 mg, 1.6 mg, 3.2 mg, 26.0 mg, 51.0 mg, 103.0 mg, 4.0 mg/mL

Tablet, film coated, , Oral, Tablet, film coated - Oral, Tablet, Tablet - Oral, Capsule, Capsule - Oral, Solution - Oral, Solution

initial treatment

160.0 mg, 320.0 mg, , 80.0 mg, 40.0 mg, 1.6 mg, 3.2 mg, 26.0 mg, 51.0 mg, 103.0 mg, 4.0 mg/mL

Tablet, film coated, , Oral, Tablet, film coated - Oral, Tablet, Tablet - Oral, Capsule, Capsule - Oral, Solution - Oral, Solution

multiple antihypertensive drugs likely required

160.0 mg, 320.0 mg, , 80.0 mg, 40.0 mg, 1.6 mg, 3.2 mg, 26.0 mg, 51.0 mg, 103.0 mg, 4.0 mg/mL

Tablet, film coated, , Oral, Tablet, film coated - Oral, Tablet, Tablet - Oral, Capsule, Capsule - Oral, Solution - Oral, Solution

not adequately controlled with monotherapy

160.0 mg, 320.0 mg, , 80.0 mg, 40.0 mg, 1.6 mg, 3.2 mg, 26.0 mg, 51.0 mg, 103.0 mg, 4.0 mg/mL

Tablet, film coated, , Oral, Tablet, film coated - Oral, Tablet, Tablet - Oral, Capsule, Capsule - Oral, Solution - Oral, Solution

Ventricular Dysfunction, Left

160.0 mg, 320.0 mg, , 80.0 mg, 40.0 mg, 1.6 mg, 3.2 mg, 26.0 mg, 51.0 mg, 103.0 mg, 4.0 mg/mL

Tablet, film coated, , Oral, Tablet, film coated - Oral, Tablet, Tablet - Oral, Capsule, Capsule - Oral, Solution - Oral, Solution

Left Ventricular Failure, Unspecified

160.0 mg, 320.0 mg, , 80.0 mg, 40.0 mg, 1.6 mg, 3.2 mg, 26.0 mg, 51.0 mg, 103.0 mg, 4.0 mg/mL

Tablet, film coated, , Oral, Tablet, film coated - Oral, Tablet, Tablet - Oral, Capsule, Capsule - Oral, Solution - Oral, Solution

Ventricular Dysfunction, Left

160.0 mg, 320.0 mg, , 80.0 mg, 40.0 mg, 1.6 mg, 3.2 mg, 26.0 mg, 51.0 mg, 103.0 mg, 4.0 mg/mL

Tablet, film coated, , Oral, Tablet, film coated - Oral, Tablet, Tablet - Oral, Capsule, Capsule - Oral, Solution - Oral, Solution

Heart Failure

160.0 mg, 320.0 mg, , 80.0 mg, 40.0 mg, 1.6 mg, 3.2 mg, 26.0 mg, 51.0 mg, 103.0 mg, 4.0 mg/mL

Tablet, film coated, , Oral, Tablet, film coated - Oral, Tablet, Tablet - Oral, Capsule, Capsule - Oral, Solution - Oral, Solution

Warnings

Valsartan Contraindications

Condition

Risk Level

Notes

Type 2 Diabetes

Do Not Combine

Breast Milk Production

Do Not Combine

Diabetes

Do Not Combine

Severe Hypersensitivity Reactions

Do Not Combine

Valsartan may interact with Pulse Frequency

There are 20 known major drug interactions with Valsartan.

Common Valsartan Drug Interactions

Drug Name

Risk Level

Description

Acenocoumarol

Major

The metabolism of Acenocoumarol can be decreased when combined with Valsartan.

Amifostine

Major

Valsartan may increase the hypotensive activities of Amifostine.

Cabozantinib

Major

The metabolism of Cabozantinib can be decreased when combined with Valsartan.

Capecitabine

Major

The metabolism of Capecitabine can be decreased when combined with Valsartan.

Cyclophosphamide

Major

The metabolism of Cyclophosphamide can be decreased when combined with Valsartan.

Valsartan Toxicity & Overdose Risk

The highest dose of valsartan that is considered toxic to rats is greater than 2000mg/kg. Studies on pregnant mice, rats, and rabbits showed no evidence of birth defects, but there were decreases in fetal weight, pup birth weight, pup survival rate, and delays in developmental milestones when the mother was given a maternally toxic dose of valsartan (600mg/kg/day) during organogenesis or late gestation and lactation. If pregnancy is detected while taking valsartan, it should be stopped as soon as possible.

image of a doctor in a lab doing drug, clinical research

Valsartan Novel Uses: Which Conditions Have a Clinical Trial Featuring Valsartan?

510 active clinical trials are presently investigating the potential of Valsartan to ameliorate Type 2 Diabetes, Diabetic Nephropathy and Hypertension.

Condition

Clinical Trials

Trial Phases

Diabetic Nephropathies

0 Actively Recruiting

Type 2 Diabetes

181 Actively Recruiting

Not Applicable, Phase 1, Phase 2, Phase 3, Phase 4, Early Phase 1

High Blood Pressure

5 Actively Recruiting

Not Applicable

Hypesthesia

5 Actively Recruiting

Not Applicable, Phase 1

Ventricular Dysfunction, Left

3 Actively Recruiting

Phase 2, Phase 3

Congestive Heart Failure

187 Actively Recruiting

Not Applicable, Phase 1, Early Phase 1, Phase 2, Phase 3, Phase 4

Hypesthesia

3 Actively Recruiting

Not Applicable

Cardiovascular Mortality

0 Actively Recruiting

Hypertensive disease

35 Actively Recruiting

Not Applicable, Phase 1, Phase 2, Phase 3

Ventricular Dysfunction, Left

0 Actively Recruiting

Combined Modality Therapy

0 Actively Recruiting

Heart Failure

0 Actively Recruiting

Left Ventricular Failure, Unspecified

0 Actively Recruiting

Hypesthesia

0 Actively Recruiting

not adequately controlled with monotherapy

0 Actively Recruiting

Hypesthesia

10 Actively Recruiting

Not Applicable, Phase 1, Phase 2, Phase 3

initial treatment

0 Actively Recruiting

multiple antihypertensive drugs likely required

0 Actively Recruiting

Valsartan Reviews: What are patients saying about Valsartan?

5

Patient Review

11/29/2017

Valsartan for High Blood Pressure

4

Patient Review

1/3/2018

Valsartan for High Blood Pressure

3.7

Patient Review

5/12/2018

Valsartan for High Blood Pressure

I felt like I was retaining water after taking valssrtan. Within two weeks, I had gained ten pounds and experienced extreme headaches and swollen fingers. After stopping the medication cold turkey, I contacted my doctor. Additionally, while on the medication I would feel short of breath and experience weakness in my arms and hips.

3.7

Patient Review

9/4/2019

Valsartan for High Blood Pressure

Although I generally had good outcomes, I was worried about the amount of weight gain.

3

Patient Review

9/21/2019

Valsartan for High Blood Pressure

This medication led to a loss of control over my bladder and bowels. I would have to get up multiple times per night, and even after discontinuing the medication, I still experience these effects albeit less frequently.

3

Patient Review

4/17/2018

Valsartan for Heart Failure

This medication has been successful in keeping my blood pressure at a healthy level for the past year. I have experienced no negative side effects and am overall very satisfied with it.

3

Patient Review

9/8/2018

Valsartan for High Blood Pressure

This medication did not help to control my blood pressure at all. If anything, it made it more erratic.

2.7

Patient Review

3/6/2022

Valsartan for High Blood Pressure

After just ten days of use, I experienced shortness of breath, blurred vision, and pain in my left side. Additionally, brain fog made me feel forgetful and off balance.

2.7

Patient Review

6/2/2022

Valsartan for Kidney Disease from Diabetes

This lowered my blood pressure but unfortunately also came with a host of nasty side effects, like body aches and an upset stomach. I had to switch to losartan 50 mg after only taking valsartan 120 mg for one month.

1.7

Patient Review

2/8/2019

Valsartan for High Blood Pressure

I was prescribed this medication for high blood pressure, but it didn't work at all. My pressure remained the same after one week of use. I'm now looking for a new physician.

1.7

Patient Review

3/23/2022

Valsartan for High Blood Pressure

While this medication does help to lower my blood pressure, the side effects are very difficult to deal with. I suffer from fatigue, insomnia, lack of concentration, and leg pain (among other things) as a result of taking this medication. Last night, I skipped taking it and was able to sleep just fine--so I'm hoping my doctor will be willing to make a change.

1.7

Patient Review

5/17/2022

Valsartan for High Blood Pressure

I stopped taking Valsartan a week ago and I feel SO much better. Dizziness was a big problem for me before, but it's gone now and I feel like a new person.

1

Patient Review

7/17/2018

Valsartan for High Blood Pressure

I am a 78-year-old woman with high blood pressure. This medication was very effective at reducing my BP, but I experienced daily back pain as a result. I will be getting off of it when a good replacement can be found.

1

Patient Review

12/25/2019

Valsartan for High Blood Pressure

I started experiencing pain after only two months of taking this medication. Additionally, I had an episode where my heart gave me a hard shock and I lost my breath. I was unable to move for about ten minutes. Once I was able to regain movement, I sought medical help and discontinue the use of this drug.

1

Patient Review

4/6/2018

Valsartan for High Blood Pressure

image of drug pills surrounding a glass of water symbolizing drug consumption

Patient Q&A Section about valsartan

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

What type of drug is valsartan?

"Valsartan is a drug that helps to lower blood pressure by blocking the tightening of blood vessels. This increased blood flow and oxygen to the heart."

Answered by AI

What should you not take with valsartan?

"Some drugs may interact with Tadalafil resulting in reduced effectiveness or increased side effects. These are:

-Certain diuretics -Ritonavir -Cyclosporine -Rifampin -Nonsteroidal anti-inflammatory drugs such as aspirin, ibuprofen, naproxen, celecoxib, diclofenac, indomethacin or meloxicam"

Answered by AI

What are side effects of valsartan?

"The following are symptoms of kidney failure: bloody urine, decreased frequency or amount of urine, difficult breathing, dizziness, faintness, or lightheadedness when getting up from a lying position, increased thirst, irregular heartbeat, numbness or tingling in the hands, feet, or lips, swelling of the face, fingers, or lower legs."

Answered by AI

What is the best time to take valsartan?

"Most people will take valsartan once or twice per day. The recommended time to take the first dose is before bedtime, as it can cause dizziness. After the first dose, valsartan can be taken at any time, although it is best to take it at the same time each day."

Answered by AI

Clinical Trials for Valsartan

Image of Institut de recherches cliniques de Montréal (IRCM) in Montreal, Canada.

Fish Oil for Type 2 Diabetes

40 - 70
All Sexes
Montreal, Canada

The purpose of this clinical trial is to find out whether one type of fish oil works better than another at improving metabolic health in people who are at high risk of developing type 2 diabetes. Some metabolic problems-such as difficulty controlling blood sugar, unhealthy particles that transport cholesterol in the blood, and poor fat tissue function-can increase the risk of type 2 diabetes. This study aims to determine whether different types of fish oil can: 1. Improve how well the body produces insulin and responds to it, 2. Improve the quality of the particles that carry "bad" cholesterol in the blood, and 3) Improve the health and function of participants' fat tissue. To answer these questions, researchers will compare the effects of two types of fish oil: EPA (eicosapentaenoic acid) and DHA (docosahexaenoic acid). These will be compared with corn oil, which is used as a placebo and does not contain EPA or DHA. When included in this study, participants will: A) Take softgel capsules containing EPA, DHA, or placebo (corn oil) every day for 12 weeks, B) Keep a daily log to record when they take their study softgels, and C) Visit the research unit six times, including one and a half days before and after the intervention, to complete specialized metabolic tests that are mostly only available in research settings.

Phase 2
Waitlist Available

Institut de recherches cliniques de Montréal (IRCM)

May Faraj, P.Dt., Ph.D.

Image of Centre de recherche du CHUS in Sherbrooke, Canada.

Cold Exposure for Type 2 Diabetes

40 - 75
All Sexes
Sherbrooke, Canada

Type 2 Diabetes Mellitus (T2DM) is a widespread health condition characterized by impaired ability of the body to maintain glucose homeostasis. This impairment often leads to secondary complications, including heart disease, high blood pressure, and poor quality of life. While exercise and healthy eating are effective strategies in managing and preventing T2DM, data shows that long-term adherence to these methods are poor - especially among elderly, individuals with obesity and/or with physical limitations. This clinical study explores cold exposure with shivering as a novel strategy to improve blood sugar control and heart health. In earlier research, spending time in mildly cold environments (around 15-17°C) for a few hours a day improved insulin sensitivity of T2DM patients. Interestingly, these benefits only occurred when the cold caused mild shivering. In a recent 10-day cold acclimation study with overt shivering for minimally 1 hour/day, we observed improved glucose tolerance in participants with overweight/obesity, as well as improved fasting lipid profiles. These results indicate that when accompanied with sufficient level of muscle activation, repeated exposure to cold can beneficially affect both glucose and lipid levels - both of which are impaired in people with T2DM. In this study, we hypothesise that a 10-day cold acclimation with shivering will improve the (peripheral) insulin sensitivity of patients with T2DM, accompanied by enhanced skeletal muscle FA uptake and oxidation as assessed via the 11C palmitate uptake.

Recruiting
Has No Placebo

Centre de recherche du CHUS

Denis P. Blondin, PhD

Image of Advanced Cardiovascular, LLC in Alexander City, United States.

NNC0487-0111 for Obesity and Heart Failure

18+
All Sexes
Alexander City, AL

This study is being done to look at the safety and effect of NNC0487-0111 in people with Heart Failure with preserved Ejection Fraction (HFpEF) or Heart Failure with mildly reduced Ejection Fraction (HFmrEF) and excess body weight when compared to placebo. The purpose of this clinical study is to find out if NNC0487-0111 is safe and effective for treating people who have HFpEF or HFmrEF and excess body weight. Participants will get NNC0487-0111 or placebo by injection once a week. Which treatment participants get is decided by chance. NNC0487-0111 is a new medicine that doctors cannot prescribe yet, but it has been tested in people before.

Phase 3
Waitlist Available

Advanced Cardiovascular, LLC (+99 Sites)

Clinical Transparency (dept. 2834)

Novo Nordisk A/S

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Image of The Ohio State University Wexner Medical Center OB/GYN Maternal and Fetal Medicine in Columbus, United States.

Nutrition Education and Support for Pregestational Diabetes

18+
Female
Columbus, OH

Nutrition insecurity (inclusive of food insecurity + poor diet quality) is a fundamental social need that must be addressed to improve treatment and health outcomes for high-risk pregnant women with pregestational type 1 and 2 diabetes, poor glucose control, and food insecurity for whom a healthy diet is critical. The NOURISH trial will provide evidence of a scalable, integrated, and theory-based healthcare-community partnership that includes weekly nutritious produce home delivery, monthly clinic-integrated diabetes, nutrition, and culinary group education, and continuous social needs assessment and support to improve glucose control and pregnancy outcomes. Given the increasing burden and devasting consequences of nutrition insecurity among high-risk pregnant women with diabetes and unmet social needs, NOURISH-an innovative and sustainable healthcare-community partnership-will have significant public health benefit.

Waitlist Available
Has No Placebo

The Ohio State University Wexner Medical Center OB/GYN Maternal and Fetal Medicine

Daniel Walker, PhD

Image of Baylor Scott and White Medical Center- Temple in Temple, United States.

Rapid Treatment Approach for Chronic Kidney Disease

18 - 84
All Sexes
Temple, TX

The goal of this clinical trial is to learn if starting four kidney disease medicines quickly and together (a rapid treatment approach) is safe and works well in people with type 2 diabetes and chronic kidney disease. The main questions it aims to answer are: * Is it safe to start these medicines over a short period of time? * How often do kidney function changes or high potassium levels occur? * Does this approach lower protein in the urine (a sign of kidney damage)? * How many participants are able to stay on all four medicines over 6 months? Researchers will compare this approach to usual care, where medicines are started one at a time over several months. Participants will: Be assigned by chance to either this approach or usual care Start up to four approved kidney medicines over about 8 weeks (rapid treatment approach) or follow standard care Have regular clinic visits and lab tests to check kidney function and potassium levels Be followed for about 6 months

Phase 4
Waitlist Available

Baylor Scott and White Medical Center- Temple

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Image of Alliance Clinical Canoga Park (Hope Clinical Research) in Canoga Park, United States.

HP-211 for Type 2 Diabetes

18+
All Sexes
Canoga Park, CA

Blood sugar levels are controlled by insulin, a hormone made by cells in the pancreas. After a meal, carbohydrates are broken down into glucose which is absorbed from the intestine into the blood leading to a rise in glucose (blood sugar) which triggers the secretion of insulin. Insulin binds to cells in several tissues including liver, muscle, and fat, triggering cells to take up glucose and bring the blood glucose level back to normal. A high blood sugar level is known as diabetes. The most common form of diabetes, type 2 diabetes, is caused by insulin resistance; that is, a reduced ability of insulin to stimulate glucose uptake into cells. The body compensates for insulin resistance by making more insulin; type 2 diabetes occurs when the pancreas can no longer make enough insulin to control blood glucose. The high blood glucose and insulin levels lead to long-term complications such as heart attacks, kidney failure, reduced sensation and poor circulation in the feet and legs. High insulin levels also increase the incidence of cancers, stroke, and dementia. Reducing blood glucose levels with oral medications and insulin reduces risk of diabetic complications. There are several types of oral medications available for treating diabetes; however, they do not always control blood glucose adequately. In addition, these drugs have complications and are not used to treat insulin resistance and prediabetes - a condition when blood glucose is higher than normal but not high enough to be classified as diabetes. Prediabetes often progresses to diabetes over a period of months or years. Effective and safe treatments for insulin resistance may prevent the onset of diabetes or even reverse diabetes if diagnosed in its early stages before substantial damage to the pancreas has occurred. HP-211 is a botanical extract whose active ingredients are derived from herbs and vegetables present in normal diets. HP-211 has been shown in laboratory studies in cell culture, in animal studies, and in a previous Phase 1 study to enhance the ability of insulin to stimulate glucose uptake into cells. Thus, HP-211 may reduce the blood glucose and circulating insulin levels of subjects with type 2 diabetes after a meal. HP-211 may also reduce glucose and insulin responses to a greater extent in insulin-resistant as compared to insulin-sensitive subjects. Subjects will take 0, 1, 2 or 3 tablets of HP-211 in the morning and evening for 90 days. Hemoglobin A1c (HbA1c, or "A1c"), a measure of the average amount of glucose present in the blood, will be measured during the trial period.

Phase 2
Recruiting

Alliance Clinical Canoga Park (Hope Clinical Research) (+24 Sites)

Housey Healthcare ULC

Image of Hāmākua-Kohala Health Center in Honokaa, United States.

Produce Prescription for High Blood Pressure

18+
All Sexes
Honokaa, HI

This multi-site randomized controlled trial uses a community-based approach to evaluate a Food as Medicine program for Native Hawaiian and Pacific Islander (NHPI) adults in Hawaii who have high blood pressure and difficulty affording healthy food. The study has two main goals: (1) to implement a produce prescription program and see if adding personal support from Community Health Workers (CHW) improves blood pressure among other health outcomes, and (2) to determine the program's cost-effectiveness. The study will take place across three Federally Qualified Health Centers in Hawaii. Produce prescription program participants at each site will receive $100 per month, either in the form of produce boxes or monthly vouchers to purchase fruits and vegetables, for 12 months (totaling $1200). In past studies, personal challenges (e.g., lack of transportation, lack of cooking skills) have made it difficult for participants to use the vouchers and/or the purchased produce. In other food as medicine interventions, participants have similarly faced various personal, social, and environmental barriers that limit the program's efficacy. To help participants navigate through these challenges, the investigators want to test adding 1-on-1 support from a CHW throughout the program. Other studies have found that health interventions delivered by CHWs have been effective in reducing blood pressure, blood glucose and weight, especially among vulnerable populations, such as NHPIs and those with food insecurity. The CHWs in this study will receive a training using a curriculum tailored specifically to their community and that is in alignment with the Pilinahā: The Four Connections Framework, which focuses on key connections that Indigenous people seek to attain health and can be employed to overcome health disparities. To test the effectiveness of the added CHW support, there will be two groups of participants: Group 1 (Intervention) will receive the monthly produce prescription ($100 vouchers or produce box) plus meet with a CHW every two months for support with program challenges. Group 2 (Control) will receive the same monthly produce prescription, but will not have meetings with a CHW. The investigators want to see if the added support from CHWs leads to better blood pressure results, among other health outcomes. Upon providing informed consent and enrolling into the program, produce prescription program participants will: * Attend 5 study visits over the one year program. These happen at the start, and then at 3, 6, 9, and 12 months. * Complete health checks at the first visit. This includes getting a home blood pressure monitor and learning about heart health and nutrition. Staff will measure height, weight, waist size, and blood pressure. * Answer surveys about their demographic background, health habits, diet, and culture. * Receive $100 in vouchers every month for 12 months to redeem for fruits and vegetables at a local retailer. * Group 1 will additionally meet with a CHW every two months for 1-on-1 support with any challenges related to the program. * Group 2 will receive monthly reminders to use their vouchers but no CHW meetings. After the program ends, researchers will analyze the financial value of the intervention. This involves calculating the total cost to run the program (including vouchers, CHW training and salaries, and administrative costs) and comparing it to potential savings in healthcare costs. By looking at improvements in blood pressure, researchers can estimate how many heart-related health problems were prevented and how much money was saved on medical care.

Waitlist Available
Has No Placebo

Hāmākua-Kohala Health Center (+2 Sites)

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