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

Not Applicable
Completed
Conditions
Obesity
Diet Modification
Diabetes Type 2
Interventions
Behavioral: High Protein Diet
Behavioral: Standard Protein Diet
Registration Number
NCT03832933
Lead Sponsor
University of Alabama at Birmingham
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.

Detailed Description

Not available

Recruitment & Eligibility

Status
COMPLETED
Sex
All
Target Recruitment
117
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.
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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.
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Study & Design

Study Type
INTERVENTIONAL
Study Design
PARALLEL
Arm && Interventions
GroupInterventionDescription
High Protein DietHigh Protein Diet-
Standard Protein DietStandard Protein Diet-
Primary Outcome Measures
NameTimeMethod
Change in body weight by weight scaleBaseline to 52 weeks

Participant body weights will be measured on a kg scale

Secondary Outcome Measures
NameTimeMethod
Change in T2D diagnosis criteriaBaseline to 52 weeks.

T2D diagnosis will be determined according to American Diabetes Association criteria, which includes fasting glucose \<126 mg/dL or hemoglobin A1c \<6.5%.

Change in % fat free mass (FFM)Baseline to 16 weeks.

Participant FFM will be measured by dual x-ray absorptiometry (DXA), which is the gold standard for measuring body composition.

Change in % FFMBaseline to 52 weeks.

Participant FFM will be measured by dual x-ray absorptiometry (DXA), which is the gold standard for measuring body composition.

Change in % body fatBaseline to 52 weeks.

Participant body fat will be measured by dual x-ray absorptiometry (DXA), which is the gold standard for measuring body composition.

Trial Locations

Locations (2)

University of Colorado Anschutz Medical Campus

🇺🇸

Aurora, Colorado, United States

University of Alabama at Birmingham

🇺🇸

Birmingham, Alabama, United States

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