Comparing High and Normal Protein Diets for the Dietary Remission of Type 2 Diabetes
1 other identifier
interventional
117
1 country
2
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P50-P75 for not_applicable
Started Jul 2019
Typical duration for not_applicable
2 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
February 5, 2019
CompletedFirst Posted
Study publicly available on registry
February 6, 2019
CompletedStudy Start
First participant enrolled
July 1, 2019
CompletedPrimary Completion
Last participant's last visit for primary outcome
April 22, 2022
CompletedStudy Completion
Last participant's last visit for all outcomes
April 22, 2022
CompletedMay 10, 2022
May 1, 2022
2.8 years
February 5, 2019
May 7, 2022
Conditions
Keywords
Outcome Measures
Primary Outcomes (2)
Change in body weight by weight scale
Participant body weights will be measured on a kg scale
Baseline to 16 weeks
Change in body weight by weight scale
Participant body weights will be measured on a kg scale
Baseline to 52 weeks
Secondary Outcomes (5)
Change in T2D diagnosis criteria
Baseline to 52 weeks.
Change in % body fat
Baseline to 16 weeks
Change in % body fat
Baseline to 52 weeks.
Change in % fat free mass (FFM)
Baseline to 16 weeks.
Change in % FFM
Baseline to 52 weeks.
Study Arms (2)
High Protein Diet
EXPERIMENTALStandard Protein Diet
ACTIVE COMPARATORInterventions
16 week weight loss and 36 weight loss maintenance intervention. Approximate macronutrient distributions (carbohydrate:protein:fat) will be 32%:40%:28%.
16 week weight loss and 36 weight loss maintenance intervention. Approximate macronutrient distributions (carbohydrate:protein:fat) will be 53%:21%:25%.
Eligibility Criteria
You may qualify if:
- 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.
You may not qualify if:
- 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.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (2)
University of Alabama at Birmingham
Birmingham, Alabama, 35294, United States
University of Colorado Anschutz Medical Campus
Aurora, Colorado, 80045, United States
Related Publications (1)
Clina JG, Sayer RD, Pan Z, Cohen CW, McDermott MT, Catenacci VA, Wyatt HR, Hill JO. High- and normal-protein diets improve body composition and glucose control in adults with type 2 diabetes: a randomized trial. Obesity (Silver Spring). 2023 Aug;31(8):2021-2030. doi: 10.1002/oby.23815.
PMID: 37475689DERIVED
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
James Hill, PhD
University of Alabama at Birmingham
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- NONE
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- Primary Investigator
Study Record Dates
First Submitted
February 5, 2019
First Posted
February 6, 2019
Study Start
July 1, 2019
Primary Completion
April 22, 2022
Study Completion
April 22, 2022
Last Updated
May 10, 2022
Record last verified: 2022-05
Data Sharing
- IPD Sharing
- Will not share