Treatment for Insulin Resistance

Phase-Based Estimates
1
Effectiveness
1
Safety
Clinical Nutrition Research Center, Chicago, IL
Insulin Resistance+3 More
Eligibility
18+
All Sexes
Eligible conditions
Insulin Resistance

Study Summary

This study is evaluating whether a strawberry extract can improve insulin sensitivity in people with diabetes.

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Eligible Conditions

  • Insulin Resistance
  • Nutrition Disorders
  • Metabolic Diseases
  • Nutritional Disease

Treatment Effectiveness

Effectiveness Estimate

1 of 3

Study Objectives

This trial is evaluating whether Treatment will improve 1 primary outcome and 1 secondary outcome in patients with Insulin Resistance. Measurement will happen over the course of 10 Weeks.

10 Weeks
The chronic beneficial effect of polyphenolics from strawberry on oxidative- and inflammatory-markers in insulin-resistant men and women
10 weeks
The chronic beneficial effect of polyphenolics from strawberry on impaired insulin signaling in insulin-resistant men and women

Trial Safety

Safety Estimate

1 of 3

Trial Design

3 Treatment Groups

Placebo2
Placebo group

This trial requires 45 total participants across 3 different treatment groups

This trial involves 3 different treatments. Treatment is the primary treatment being studied. Participants will all receive the same treatment. Some patients will receive a placebo treatment. The treatments being tested are not being studied for commercial purposes.

Placebo2
DietarySupplement
Placebo Beverage 2 with Fiber
Placebo1
DietarySupplement
Placebo Beverage 1 without fiber
Strawberry
DietarySupplement
Strawberry Beverage 20g/BID

Trial Logistics

Trial Timeline

Approximate Timeline
Screening: ~3 weeks
Treatment: Varies
Reporting: 10 weeks
This trial has the following approximate timeline: 3 weeks for initial screening, variable treatment timelines, and roughly 10 weeks for reporting.

Closest Location

Clinical Nutrition Research Center - Chicago, IL

Eligibility Criteria

This trial is for patients born any sex aged 18 and older. There are 9 eligibility criteria to participate in this trial as listed below.

Mark “yes” if the following statements are true for you:
was independently associated with both prevalent and incident T2D in a cohort of Japanese adults The study found that people with fasting insulin levels above the 75th percentile (13.13 μU/mL) were more likely to have T2D, both currently and in the future. show original
The homeostasis model assessment of insulin resistance (HOMA-IR) values of at least 2.5 indicate insulin resistance. show original
was found in any subject No clinically apparent cardiovascular, metabolic, respiratory, renal, gastrointestinal, or hepatic disease was found in any subject. show original
Elevated fasting glucose (110 mg/dL≤ Fasting blood glucose <126 mg/dL)
Having a waist circumference of ≥ 110 cm is associated with an increased risk of insulin resistance. show original
Nonsmokers
The participants agreed not to take any medications that would interfere with the study results, including lipid-lowering medications, anti-inflammatory drugs, and dietary supplements. show original
People who are 18 years old or older are allowed to vote. show original
Your blood glucose concentration is within the normal range if it is between 140 and 199 mg/dL after two hours from the start of the OGTT. show original

Patient Q&A Section

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

What are the latest developments in treatment for therapeutic use?

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Therapeutic approaches for type 2 diabetes are evolving rapidly and are likely to be influenced by advances in basic science, technology, and knowledge into new pharmacologic and pharmacotherapies.

Unverified Answer

What is insulin resistance?

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Insulin resistance is a wide label that refers to a range of inherited and acquired conditions that cause insulin resistance. In the US, this is not a rare disorder, but it can be difficult to identify in elderly patients. It can occur in the absence of other signs or symptoms. Insulin resistance can lead to disturbances in lipid and glucose profiles, and it is associated with the metabolic syndrome and its derivatives, especially with visceral obesity. The link between the insulin resistance and adipose tissue, skeletal muscle, and liver may explain some of the risks of being overweight or obese. The exact mechanisms involved are poorly understood, and the underlying mechanisms are currently under investigation; however, it is believed that they relate to increased hepatic fat and low HDL cholesterol.

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What are the signs of insulin resistance?

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Insulin resistance is a major issue in the management of type 2 diabetes. It is caused by a combination of genetic and environmental influences. An assessment of IR can be done using either the HOMA index or a fasting plasma glucose level. Insulin resistance can also be assessed by using the fasting insulin level. Fasting insulin levels reflect more closely than the HOMA index the degree and type of insulin resistance.

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What causes insulin resistance?

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A strong genetic predisposition of insulin resistance appears to be associated with type 2 diabetes mellitus. However, we found that other non-diabetic and non-diabetic women with chronic hypocaloric diets had elevated insulin resistance. We hypothesize that changes in the female hormonal milieu are responsible for this discrepancy.

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Can insulin resistance be cured?

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A reduction in HOMA-IR can be seen in obese patients who enter lifestyle modification programs. However, the improvement in HOMA-IR is more likely due to an increase in the baseline baseline HOMA-IR, rather than improvements in the metabolic parameters in the obese patients.

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What are common treatments for insulin resistance?

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Insulin resistance is generally difficult to treat, although it does improve on a gluten-free diet, low-fat diet, or CBT. Some medications may be able to improve the insulin resistance. Patients are advised to keep a general practitioner close by as a precaution.

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How many people get insulin resistance a year in the United States?

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[About 75% of adults have insulin resistance at the beginning of the morning, which increases during the course of the day, and may reach the high range at night] (Hendrik and colleagues 2012). These numbers are consistent with those seen in several studies of [African-Americans] and [Americans of different geographic origins]. (Keller et al. 1992, Deuel et al. 1993; Fajardo and colleagues 2005; Meck et al. 2012; and Mendes, Garcia, and colleagues 2016, e.g.

Unverified Answer

What is treatment?

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The most important aspect of treatment of patients with type 2 diabetes mellitus is achieving good metabolic control: the best treatment should be based on patient's needs, as well as on physicians' and patients' preferences.

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What does treatment usually treat?

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Results from a recent clinical trial shows that patients will continue to have high blood glucose levels despite treatment in a large proportion of patients with T2DM over the long term in the real world of clinical practice. Clinical practice should consider the need to assess not just blood glucose management but treatment targets at an individual level to ensure that treatment strategies are effective.

Unverified Answer

Who should consider clinical trials for insulin resistance?

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The majority of patients with IR and type 2 diabetes with an elevated FPG but normal HOMA-IR are either normal weight or obese. Therefore, patients do not represent a significant subgroup within the IR-T2D population for clinical trials for IR. We now recommend FPG as the primary surrogate end point for clinical trials in IR.

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Is treatment typically used in combination with any other treatments?

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Combination therapies are utilized in 25% of patients receiving insulin therapy without an improvement in long-term glycemic control. These combinations must be carefully examined and carefully implemented in the design of the research protocol.

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Does treatment improve quality of life for those with insulin resistance?

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The effects of treatment on quality of life and mood were similar and were likely to be a result of the decreased insulin resistance with metformin. The combination of insulin resistance and metabolic disturbances had a negative impact on both quality of life and mood.

Unverified Answer
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