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

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ClinicalTrials.gov Identifier: NCT03832933
Recruitment Status : Not yet recruiting
First Posted : February 6, 2019
Last Update Posted : February 15, 2019
Sponsor:
Information provided by (Responsible Party):
James O. Hill, 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.

Condition or disease Intervention/treatment Phase
Diabetes Type 2 Obesity Diet Modification Behavioral: High Protein Diet Behavioral: Standard Protein Diet Not Applicable

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 180 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Comparing High and Normal Protein Diets for the Dietary Remission of Type 2 Diabetes
Estimated Study Start Date : April 1, 2019
Estimated Primary Completion Date : September 30, 2020
Estimated Study Completion Date : September 30, 2021

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Experimental: High Protein Diet Behavioral: High Protein Diet
16 week weight loss and 36 weight loss maintenance intervention. Approximate macronutrient distributions (carbohydrate:protein:fat) will be 32%:40%:28%.

Active Comparator: Standard Protein Diet Behavioral: Standard Protein Diet
16 week weight loss and 36 weight loss maintenance intervention. Approximate macronutrient distributions (carbohydrate:protein:fat) will be 53%:21%:25%.




Primary Outcome Measures :
  1. Change in body weight by weight scale [ Time Frame: Baseline to 16 weeks ]
    Participant body weights will be measured on a kg scale

  2. Change in body weight by weight scale [ Time Frame: Baseline to 52 weeks ]
    Participant body weights will be measured on a kg scale


Secondary Outcome Measures :
  1. Change in T2D diagnosis criteria [ Time Frame: Baseline 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%.

  2. Change in % body fat [ Time Frame: Baseline to 16 weeks ]
    Participant body fat will be measured by dual x-ray absorptiometry (DXA), which is the gold standard for measuring body composition.

  3. Change in % body fat [ Time Frame: Baseline to 52 weeks. ]
    Participant body fat will be measured by dual x-ray absorptiometry (DXA), which is the gold standard for measuring body composition.

  4. Change in % fat free mass (FFM) [ Time Frame: Baseline to 16 weeks. ]
    Participant FFM will be measured by dual x-ray absorptiometry (DXA), which is the gold standard for measuring body composition.

  5. Change in % FFM [ Time Frame: Baseline to 52 weeks. ]
    Participant FFM will be measured by dual x-ray absorptiometry (DXA), which is the gold standard for measuring body composition.



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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03832933


Contacts
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Contact: Drew Sayer, PhD 205-354-8950 sayerd@uab.edu

Locations
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United States, Alabama
University of Alabama at Birmingham Not yet recruiting
Birmingham, Alabama, United States, 35294
Contact: Drew Sayer, PhD         
United States, Colorado
University of Colorado Anschutz Medical Campus Not yet recruiting
Aurora, Colorado, United States, 80045
Contact: Jeanne Breen, MS    303-724-9015    JeanneAnne.Breen@ucdenver.edu   
Sponsors and Collaborators
University of Alabama at Birmingham
Investigators
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Principal Investigator: James Hill, PhD University of Alabama at Birmingham

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Responsible Party: James O. Hill, Primary Investigator, University of Alabama at Birmingham
ClinicalTrials.gov Identifier: NCT03832933     History of Changes
Other Study ID Numbers: IRB-12345678
First Posted: February 6, 2019    Key Record Dates
Last Update Posted: February 15, 2019
Last Verified: February 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No

Keywords provided by James O. Hill, University of Alabama at Birmingham:
weight loss
dietary protein

Additional relevant MeSH terms:
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Diabetes Mellitus
Diabetes Mellitus, Type 2
Glucose Metabolism Disorders
Metabolic Diseases
Endocrine System Diseases