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



Status:Not yet recruiting
Conditions:Obesity Weight Loss, Diabetes, Diabetes
Therapuetic Areas:Endocrinology
Healthy:No
Age Range:18 - Any
Updated:2/17/2019
Start Date:April 1, 2019
End Date:September 30, 2021
Contact:Drew Sayer, PhD
Email:sayerd@uab.edu
Phone:205-354-8950

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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.


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.
We found this trial at
2
sites
1720 2nd Ave S
Birmingham, Alabama 35233
(205) 934-4011 
University of Alabama at Birmingham The University of Alabama at Birmingham (UAB) traces its roots...
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13001 E 17th Pl
Aurora, Colorado 80045
(303) 724-5000
Phone: 303-724-9015
University of Colorado Anschutz Medical Campus Located in the Denver metro area near the Rocky...
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