Comparing High and Normal Protein Diets for the Dietary Remission of Type 2 Diabetes

The University of Alabama at Birmingham

Status

Completed

Conditions

Obesity

Diet Modification

Diabetes Type 2

Treatments

Behavioral: High Protein Diet

Behavioral: Standard Protein Diet

Study type

Interventional

Funder types

Other

Identifiers

NCT03832933

IRB-300002928

Details and patient eligibility

About

The purpose of this study is to examine the impact of high protein (HP) vs. normal protein (NP) diets on weight loss, loss of fat free mass (FFM), and remission of type 2 diabetes (T2D) in individuals with T2D. Both diet groups will receive dietary and physical activity guidance through a group-based weight loss program, State of Slim (SOS). The central hypothesis is that the HP diet (with ≥4 weekly servings of lean beef) will lead to greater remission of T2D vs. a NP diet by 1) producing greater weight loss and limiting weight regain and 2) preferentially reducing fat mass while preserving FFM.

Enrollment

117 patients

Sex

All

Ages

18+ years old

Volunteers

No Healthy Volunteers

Inclusion criteria

Male or female
Age ≥18 years
T2D diagnosis within previous 6 years (documented physician diagnosis, use of antidiabetic medication, fasting glucose ≥126 mg/dl, and/or HbA1c ≥6.5%)
BMI of ≥27 kg/m2
Weight stable (±3kg in the last 3 months)
Participants using GLP-1 agonists or SLGT-inhibitors must be on a stable (≥3 months) medication dosage and not be planning to change medication dosage
Willing and able to participate in a weekly group class for the first 16 weeks of the study, bi-weekly classes for the remainder of the study, and willing to participate in 4 study visits over the 52 week study period.

Exclusion criteria

HbA1c concentration of ≥12%.
Pregnant or lactating within the past 6 months or trying to become pregnant.
Individuals following a vegetarian/vegan only diet
Food allergies (to red meats or other common protein sources)
Using exogenous insulin for T2D management
Taking other medications that could cause weight loss or weight gain (such as steroids, tricyclic antidepressants, chemotherapy, antipsychotics, prescribed or OTC weight loss agents). Oral contraceptives can be used as long as subject agrees to not change use of these during the study. Vitamins and minerals that do not have a weight effect are allowed as long as use is continued without change during the study.
Current alcohol or drug abuse or dependence (Subjects who have quit smoking in the last 6 months will be excluded. Smokers whose smoking habits have been stable for the last 6 months and which remain stable during the study can be included).
Current Eating disorder (anorexia or bulimia)
Any medical condition for which following a high protein diet and/or 70 minutes of exercise daily would be inadvisable.
Untreated or unstable hypothyroidism. Thyroid medications must be stable for at least 3 months.