Low-Carb Diet for Type 2 Diabetes

Overseen by Ortal Resnick, MD

Age: < 65

Sex: Any

Travel: May Be Covered

Time Reimbursement: Varies

Trial Phase: Phase < 1

Waitlist Available

Sponsor: University of Alabama at Birmingham

No Placebo Group

Trial Summary

What is the purpose of this trial?

The purpose of this project is to test the effect of a low carb diet compared to standard carb diet among adolescents with T2D over a 24-week period.

Research Team

Ortal Resnick, MD

Principal Investigator

University of Alabama at Birmingham

Eligibility Criteria

This trial is for adolescents aged 12-18 with Type 2 Diabetes, who have an HbA1C level between 6.5-8.5% and a BMI above the 85th percentile. Participants should not be on insulin but can be taking certain diabetes medications like GLP-1, metformin, or SGLT-2 inhibitors as long as doses have been stable for three months.

Inclusion Criteria

HbA1C between 6.5-8.5%

BMI >85th percentile

Negative pancreatic autoantibodies

Exclusion Criteria

I am currently being treated with insulin.

My kidney function is impaired with creatinine over 1 mg/dL.

My liver tests (AST and ALT) are above 100 IU/ml.

Treatment Details

Interventions

• Low Carb Diet (Behavioral Intervention)

Trial Overview The study compares the effects of a low-carb diet to a standard diabetic diet over six months in young patients with Type 2 Diabetes. The goal is to see which diet better manages blood sugar levels.

Participant Groups

Group I: Low carb diet Active Control 1 Intervention

Participants in this group will limit the amount of carbohydrates they eat each day to 50-80 grams. This means eating fewer sugars and starches (like bread, pasta, rice, and sweets). Instead, meals will focus on protein, healthy fats, and non-starchy vegetables. Participants will track their food and meet with a dietitian to help them stick to the plan.

Group II: Standard of care Active Control 1 Intervention

Participants in this group will follow the current standard diet for managing diabetes. This includes balanced meals with carbohydrates, protein, and fats, based on regular diabetes guidelines. Participants will track their food and meet with a dietitian to help them stay on track.

Who Is Running the Clinical Trial?

University of Alabama at Birmingham

Lead Sponsor

Trials

1,677

Recruited

2,458,000+

Kierstin Kennedy

University of Alabama at Birmingham

Chief Medical Officer since 2022

MD

S. Dawn Bulgarella

University of Alabama at Birmingham

Chief Executive Officer since 2023

BSc in Commerce and Business Administration from the University of Alabama, MS in Health Administration from the University of Alabama at Birmingham

Children's of Alabama

Collaborator

Trials

10

Recruited

3,000+