Clinical trial NCT03832933: Comparing High and Normal Protein Diets for the Dietary Remission of Type 2 Diabetes
Official title: Comparing High and Normal Protein Diets for the Dietary Remission of Type 2 Diabetes
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Diabetes Type 2
Obesity
Diet Modification
Keywords: weight loss
dietary protein
Lead sponsor: University of Alabama at Birmingham
Sponsor class: OTHER
First posted: 2019-02-06
Enrollment: 117
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: 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.


Eligibility criteria: 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.

Primary outcomes:
measure: Change in body weight by weight scale
timeFrame: Baseline to 16 weeks
measure: Change in body weight by weight scale
timeFrame: Baseline to 52 weeks
Secondary outcomes:
measure: Change in T2D diagnosis criteria
timeFrame: Baseline to 52 weeks.
measure: Change in % body fat
timeFrame: Baseline to 16 weeks
measure: Change in % body fat
timeFrame: Baseline to 52 weeks.
measure: Change in % fat free mass (FFM)
timeFrame: Baseline to 16 weeks.
measure: Change in % FFM
timeFrame: Baseline to 52 weeks.
Other outcomes:
Locations:
city: Birmingham
country: United States
facility: University of Alabama at Birmingham
state: Alabama
city: Aurora
country: United States
facility: University of Colorado Anschutz Medical Campus
state: Colorado
Study officials:
affiliation: University of Alabama at Birmingham
name: James Hill, PhD
role: PRINCIPAL_INVESTIGATOR
References: