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Behavioural Intervention

Low Glycemic Diet for Type 2 Diabetes

Q: How many participants have been recruited into this clinical investigation?

Affirmative. Clinicaltrials.gov data shows that this medical experiment, which was initially posted on October 9th 2018 is still recruiting participants. It necessitates 80 individuals from a single clinic to be enrolled in the trial.

Q: Are individuals of advanced age being enrolled in this trial?

The current recruitment process is targeting adults between the ages of 35 and 65.

Q: To which demographic is this research endeavor open?

This medical experiment is welcoming 80 individuals with <a href="https://www.withpower.com/clinical-trials/type-2-diabetes">type 2 diabetes</a> between the ages of 35 and 65. The primary eligibility requirements are as follows: Diagnosed within the last decade, treated using dietary changes or metformin/DPP-IV inhibitors, aged 35 to 65 years old, Hemoglobin A1c &#x3C;7.0, African American or European American racial background, BMI 25-45 kg/m2 (no more than 5kg change in past 6 months).

Q: Is recruitment for this clinical trial still open?

Affirmative. Clinicaltrials.gov verifies that this study is presently seeking enrollees and was first advertised on October 9th, 2018 with its most recent update occurring April 6th 2022. The experiment requires 80 volunteers to be registered at 1 medical facility.

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

Study 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 weeks3 visits

Treatment ~ Varies

Follow Up ~ 12 weeks

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.

0 / 3Eligibility criteria met

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Who is running the clinical trial?

University of Alabama at BirminghamLead Sponsor

1,581 Previous Clinical Trials

2,277,964 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: Control Diet, Low Glycemic 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

Frequently Asked Questions

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

How many participants have been recruited into this clinical investigation?

"Affirmative. Clinicaltrials.gov data shows that this medical experiment, which was initially posted on October 9th 2018 is still recruiting participants. It necessitates 80 individuals from a single clinic to be enrolled in the trial."

Answered by AI

Are individuals of advanced age being enrolled in this trial?

"The current recruitment process is targeting adults between the ages of 35 and 65."

Answered by AI

To which demographic is this research endeavor open?

"This medical experiment is welcoming 80 individuals with type 2 diabetes between the ages of 35 and 65. The primary eligibility requirements are as follows: Diagnosed within the last decade, treated using dietary changes or metformin/DPP-IV inhibitors, aged 35 to 65 years old, Hemoglobin A1c <7.0, African American or European American racial background, BMI 25-45 kg/m2 (no more than 5kg change in past 6 months)."

Answered by AI

Is recruitment for this clinical trial still open?

"Affirmative. Clinicaltrials.gov verifies that this study is presently seeking enrollees and was first advertised on October 9th, 2018 with its most recent update occurring April 6th 2022. The experiment requires 80 volunteers to be registered at 1 medical facility."

Answered by AI

Recent research and studies

clinicaltrials.govStudy

Return of First-phase Insulin Secretion in Type 2 Diabetes is Associated With Depletion of Pancreas Lipid

Barbara Gower 2018. "Return of First-phase Insulin Secretion in Type 2 Diabetes is Associated With Depletion of Pancreas Lipid". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT03430310.