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

Obesity Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03832933
• Other study ID #: IRB-300002928
• Status: Completed
• Phase: N/A
• Start date: July 1, 2019
• Est. completion date: April 22, 2022

Study information

• Verified date: May 2022
• Source: University of Alabama at Birmingham
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 117
• Est. completion date: April 22, 2022
• Est. primary completion date: April 22, 2022
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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.

Related Conditions & MeSH terms

• Diabetes Mellitus
• Diabetes Mellitus, Type 2
• Diabetes Type 2
• Diet Modification
• Obesity

Intervention

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

Locations

Country	Name	City	State
United States	University of Colorado Anschutz Medical Campus	Aurora	Colorado
United States	University of Alabama at Birmingham	Birmingham	Alabama

Sponsors (1)

Lead Sponsor	Collaborator
University of Alabama at Birmingham

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Change in body weight by weight scale	Participant body weights will be measured on a kg scale	Baseline to 16 weeks
Primary	Change in body weight by weight scale	Participant body weights will be measured on a kg scale	Baseline to 52 weeks
Secondary	Change in T2D diagnosis criteria	T2D diagnosis will be determined according to American Diabetes Association criteria, which includes fasting glucose <126 mg/dL or hemoglobin A1c <6.5%.	Baseline to 52 weeks.
Secondary	Change in % body fat	Participant body fat will be measured by dual x-ray absorptiometry (DXA), which is the gold standard for measuring body composition.	Baseline to 16 weeks
Secondary	Change in % body fat	Participant body fat will be measured by dual x-ray absorptiometry (DXA), which is the gold standard for measuring body composition.	Baseline to 52 weeks.
Secondary	Change in % fat free mass (FFM)	Participant FFM will be measured by dual x-ray absorptiometry (DXA), which is the gold standard for measuring body composition.	Baseline to 16 weeks.
Secondary	Change in % FFM	Participant FFM will be measured by dual x-ray absorptiometry (DXA), which is the gold standard for measuring body composition.	Baseline to 52 weeks.