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Behavioural Intervention

Low Glycemic Diet for Type 2 Diabetes

N/A
Waitlist Available
Research Sponsored by University of Alabama at Birmingham
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
Treated with diet, Metformin, or dipeptidyl peptidase 4 (DPP-IV) inhibitors
Adult men and women age 35-65 yr
Timeline
Screening 3 weeks
Treatment Varies
Follow Up 12 weeks
Awards & highlights

Summary

This trial is testing the hypothesis that reducing dietary glycemic load will decrease pancreas lipid and improve beta-cell function in patients with early Type 2 Diabetes, especially African-Americans.

Who is the study for?
This trial is for overweight adults aged 35-65 with stable weight, diagnosed with Type 2 Diabetes in the last 10 years, and currently treated with diet or specific diabetes medications. Participants should have a Hemoglobin A1c below 7.0 and be of African American or European American descent. Smokers, drug users, those with certain kidney/liver issues, or unable to undergo MRI are excluded.Check my eligibility
What is being tested?
The study tests if a Low Glycemic Diet can reduce pancreas fat and improve insulin secretion without losing weight, especially comparing African-Americans to European-Americans. It explores whether this diet change alone can recover beta-cell function in early Type 2 Diabetes patients.See study design
What are the potential side effects?
Since the interventions involve dietary changes rather than medication adjustments (beyond current treatments), significant side effects are not anticipated; however, individual responses to diet alterations may vary.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below
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I am managing my condition with diet, Metformin, or DPP-IV inhibitors.
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I am between 35 and 65 years old.
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I was diagnosed with Type 2 Diabetes in the last 10 years.

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~12 weeks
This trial's timeline: 3 weeks for screening, Varies for treatment, and 12 weeks for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.
Primary outcome measures
Pancreas lipid
Secondary outcome measures
Insulin secretion

Trial Design

2Treatment groups
Experimental Treatment
Placebo Group
Group I: Low Glycemic DietExperimental Treatment1 Intervention
The investigators will use a Low Glycemic Load Diet (LG Diet), which emphasizes low-glycemic sources of carbohydrate, and includes mainly whole foods (vegetables, fruits, whole grains) with minimal highly processed grain products and added sugar. Protein foods will include meat, poultry, fish, eggs, and whey protein supplements if necessary (e.g., for vegetarians). Fat-containing foods will include olive, coconut, and nut oils; butter; tree nuts and nut butters; cheese; cream; coconut milk; avocados; and the fat found in meat. A number of full-fat dairy products will be included. Saturated fat from red meat will be limited to less than 10% of daily caloric intake. Participants will obtain the majority of their fat intake from mono-unsaturated fatty acids (e.g. olive oil), and medium-chain triglycerides (e.g., coconut oil and cream); from nuts and nut butters; and from fresh fish.
Group II: Control DietPlacebo Group1 Intervention
The Control diet will be compatible with both the American Diabetes Association and The United States Department of Agriculture guidelines. Participants will be given low-fat foods, whole-grain foods, fruits, and vegetables. The meal plans will minimize cholesterol, high-fat foods, high-cholesterol foods, processed starches, and added sugar, and will provide <2300 mg/day sodium. Saturated fat will be limited to less than 10% of total energy, and all dairy products will be fat-free (or low-fat). Although the Control diet will be a healthful diet, it will include a greater amount of carbohydrate foods from such sources as bread, potatoes, and pasta that will distinguish it qualitatively from the LG diet. In addition, it will have quantitatively more total energy from carbohydrate than the LG diet.

Find a Location

Who is running the clinical trial?

University of Alabama at BirminghamLead Sponsor
1,599 Previous Clinical Trials
2,287,855 Total Patients Enrolled

Media Library

Low Glycemic Diet (Behavioural Intervention) Clinical Trial Eligibility Overview. Trial Name: NCT03430310 — N/A
Type 2 Diabetes Research Study Groups: Low Glycemic Diet, Control Diet
Type 2 Diabetes Clinical Trial 2023: Low Glycemic Diet Highlights & Side Effects. Trial Name: NCT03430310 — N/A
Low Glycemic Diet (Behavioural Intervention) 2023 Treatment Timeline for Medical Study. Trial Name: NCT03430310 — N/A
~10 spots leftby Jul 2025
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