Treatment for Diabetes Mellitus, Type 2

Phase-Based Estimates
1
Effectiveness
1
Safety
University of Tennessee Health Science Center, Memphis, TN
Diabetes Mellitus, Type 2+3 More
Eligibility
18 - 65
All Sexes
Eligible conditions
Diabetes Mellitus, Type 2

Study Summary

This study is evaluating whether a high protein diet may help individuals with type 2 diabetes to achieve remission.

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Eligible Conditions

  • Diabetes Mellitus, Type 2
  • Diabetes Mellitus
  • Newly Diagnosed Type 2 Diabetes
  • Obese

Treatment Effectiveness

Effectiveness Estimate

1 of 3

Study Objectives

This trial is evaluating whether Treatment will improve 1 primary outcome and 4 secondary outcomes in patients with Diabetes Mellitus, Type 2. Measurement will happen over the course of Each subject will be monitored for 6 months while they are on the HP or HC diet.

Month 6
Cardiovascular Risk Factors (CVR)
Inflammation markers such as cytokines
Metabolom Markers
Weight loss
Month 6
Remission of Type 2 Diabetes

Trial Safety

Safety Estimate

1 of 3

Trial Design

2 Treatment Groups

High protein (HP) weight loss diet

This trial requires 100 total participants across 2 different treatment groups

This trial involves 2 different treatments. Treatment is the primary treatment being studied. Participants will all receive the same treatment. There is no placebo group. The treatments being tested are not being studied for commercial purposes.

High protein (HP) weight loss diet
Other
A weight loss high protein (HP) (30% Kcal protein, 40% Kcal carbohydrate (CHO) and 30% Kcal fat) diet will be given to the subjects on that arm of study to pick up weekly for 6 months.
High carbohydrate (HC) weight loss diet
Other
A weight loss high carbohydrate (HC) (15% Kcal protein, 55% Kcal CHO and 30% Kcal fat) diet will be given to the subjects on that arm of study to pick up weekly for 6 months. Intervention with the HC diet will be 6 months. If subjects have not had remission of Type 2 Diabetes by the end of the 6 months, they will be referred to an endocrinologist for pharmaceutical treatment

Trial Logistics

Trial Timeline

Approximate Timeline
Screening: ~3 weeks
Treatment: Varies
Reporting: each subject will be monitored for 6 months while they are on the hp or hc diet
This trial has the following approximate timeline: 3 weeks for initial screening, variable treatment timelines, and roughly each subject will be monitored for 6 months while they are on the hp or hc diet for reporting.

Who is running the study

Principal Investigator
F. S.
Prof. Frankie Stentz, Professor/ Department of Medicine/Endocrinology, Diabetes and Metabolism
University of Tennessee Health Science Center

Closest Location

University of Tennessee Health Science Center - Memphis, TN

Eligibility Criteria

This trial is for patients born any sex between 18 and 65 years old. You must have received newly diagnosed for Diabetes Mellitus, Type 2 or one of the other 3 conditions listed above. There are 2 eligibility criteria to participate in this trial as listed below.

Mark “yes” if the following statements are true for you:
i) Age range 20 yrs to 50 yrs; ii) BMI > 30 kg/m2 to 55kg/m2; iii). Fasting blood glucose >126 mg/dl and 2 hour glucose >200 mg/dl determined by OGTT; iv). HbA1c > 6.5 % to ≤10%.
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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 signs of diabetes mellitus, type 2?

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Symptoms of diabetes mellitus, type 2 include not eating often or for extended periods of time, frequent urination, and increased thirst and/or thirsting. Increased irritability, excessive sleeping or difficulty sleeping, blurry vision, and/or feeling tired are also common.

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How many people get diabetes mellitus, type 2 a year in the United States?

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About 31.6 million Americans have diabetes mellitus, type 2, with 10 million new cases diagnosed each year in the last 5 years, making it the third leading cause of disability in the US.

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What is diabetes mellitus, type 2?

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Type 2 diabetes is a diabetes mellitus which is characterized by high blood sugar levels and is associated with a high risk of cardiovascular complications, such as diabetic neuropathy, diabetic retinopathy and impaired renal function. The number of individuals affected with type 2 diabetes and its incidence are increasing.

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Can diabetes mellitus, type 2 be cured?

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Diabetes can be cured for about half of individuals; the cause of cure most likely belongs to a unique combination of genetic susceptibility and environmental factors.

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What causes diabetes mellitus, type 2?

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The cause of diabetes mellitus type 2 is thought to be due to an interaction of genetic and environmental factors at birth. The risk factors include a lack of exercise in early life, poor diet, physical inactivity, and familial clustering of affected relatives. Diabetes Mellitus Type 2 is highly prevalent and is a major cause of diabetic complications. It is the cause of death of around one million individuals in the UK each year. The average age at the onset of diabetes mellitus type 2 is 40, but the average age of diagnosis is 62. The lifetime risk of developing diabetes mellitus type 2 is around 20%; as the condition can take years to develop it is a chronic condition.

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What are common treatments for diabetes mellitus, type 2?

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In Canada, Canada has a unique specialty of endocrinology—primary care gastroenterology, as well as a specialist system of diabetes management. The Canadian Diabetes Association is the accrediting body for diabetes mellitus, type 2. In 2011, the Canadian Diabetes Association published recommendations for care practices in Canada, particularly for diabetes mellitus, type 2, as well as for treatment of its complications: hyperglycemia and diabetes complications.\n

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How serious can diabetes mellitus, type 2 be?

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Diabetes mellitus, type 2 is a chronic disease that can lead to many complications (see Diabetes complications and sequelae section). These complications can lead to disability, reduced quality of life, or even death. Diabetes is an independent predictor of complications in older adults. As people with diabetes approach their 60s, they can be identified as being at an increased risk of developing many complications from diabetes. Older adults with diabetes, as well as their caregivers, are encouraged to work together to help them achieve an optimal quality of life. Diabetes mellitus, type 2 is particularly dangerous during pregnancy because it can affect a mother's ability to get pregnant and a mother's ability to have a healthy baby.

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What is the latest research for diabetes mellitus, type 2?

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The incidence of diabetes rises as people ages. The rate of new cases with diabetes rises every year after the age of 40 in industrialized countries. Diabetes is not only a diabetes syndrome but also a large spectrum disease that is associated with a number of related disease conditions, some of which have become prevalent in contemporary society. In developing countries such as China, diabetes remains one of the common public health challenges. The burden of diabetes as a public health problem, whether in the form of type 2 diabetes or gestational diabetes, is increasing.

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What are the common side effects of treatment?

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Findings from a recent study shows the commonly recognized and most common side effects for which patients with type 2 diabetes mellitus (T2DM) typically are treated. Patients must be advised to evaluate the side effects for each treatment strategy in detail before making the choices and decisions. Physicians need to be aware of the most common side effects and discuss these for each treatment strategy in detail with their patients. Physicians can then choose the treatment strategy that would be most ideal based on their assessment of the benefits and risks of each treatment and based on the patient's needs. A complete list of common side effects is given in Table 1.

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Have there been other clinical trials involving treatment?

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The answer to the second question is yes, and the third question is no.\n\nThe United Kingdom's National Health Service defines the clinical trial as follows:\n"A clinical trial on a person is a controlled study and is a random allocation of experimental units to different groups in which the results inform a particular decision or conclusions regarding the units in the trial. These units are called patients and the data collected represents them; in clinical trials the results are evaluated regarding a person. Clinical trials comprise an assessment of a patient's health state in order to furnish evidence of the safety and efficacy [efficacy?] of an experimental treatment or intervention.

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Does treatment improve quality of life for those with diabetes mellitus, type 2?

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Data from a recent study suggests the effectiveness of conventional therapy for Type 2 DM on QoL outcomes. Data from a recent study also indicate that treatment could improve QoL outcomes for diabetic patients.

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What is treatment?

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This article presents a concise, systematic guide to the types and amounts of blood glucose levels expected during treatment with metformin. The use of an online calculator that works with an insulin pump is presented to help patients calculate future blood glucose levels safely and effectively, and to aid in the management of diabetes.

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