Diabetes Type 2NCT03832933
Comparing High and Normal Protein Diets for the Dietary Remission of Type 2 Diabetes
A study testing High Protein Diet and Standard Protein Diet in people with Diabetes Type 2 and Obesity, run by University of Alabama at Birmingham at 2 sites in United States.
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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Diabetes Type 2, Obesity, Diet Modification
- What is being tested?
- High Protein Diet and Standard Protein Diet
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 117 participants
- Where
- 2 sitesUnited States
- Study dates
- 1 Jul 2019to 22 Apr 2022
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- 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.
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- 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.
Trial locations and contacts
2 sites in 1 country.
United States2 sites
University of Colorado Anschutz Medical Campus
Aurora, Colorado, 80045
University of Alabama at Birmingham
Birmingham, Alabama, 35294
About this study
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.
- Conditions
- Diabetes Type 2, Obesity, Diet Modification
- Being tested
- High Protein Diet, Standard Protein Diet
- Keywords
- weight loss, dietary protein
- Medical subject headings
- Diabetes Mellitus, Type 2, Obesity, Weight Loss
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
High Protein DietBehavioural
16 week weight loss and 36 weight loss maintenance intervention. Approximate macronutrient distributions (carbohydrate:protein:fat) will be 32%:40%:28%.
Standard Protein DietBehavioural
16 week weight loss and 36 weight loss maintenance intervention. Approximate macronutrient distributions (carbohydrate:protein:fat) will be 53%:21%:25%.
| Study group | Role | What they receive |
|---|---|---|
| High Protein Diet | Experimental | Not described Receives: Behavioral: High Protein Diet |
| Standard Protein Diet | Active comparator | Not described Receives: Behavioral: Standard Protein Diet |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in body weight by weight scale
Participant body weights will be measured on a kg scale
Measured: Baseline to 16 weeks
Change in body weight by weight scale
Participant body weights will be measured on a kg scale
Measured: Baseline to 52 weeks
Secondary outcomes (5)
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%.
Measured: Baseline to 52 weeks.
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.
Measured: Baseline to 16 weeks
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.
Measured: Baseline to 52 weeks.
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.
Measured: Baseline to 16 weeks.
Change in % FFM
Participant FFM will be measured by dual x-ray absorptiometry (DXA), which is the gold standard for measuring body composition.
Measured: Baseline to 52 weeks.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted6 Feb 2019
- Study start1 Jul 2019
- Primary completion22 Apr 2022
- Study completion22 Apr 2022
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Diabetes Type 2Studies of the same condition, open and under way.
- More trials run by University of Alabama at BirminghamThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 117 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Alabama at Birmingham
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, James O. Hill, University of Alabama at Birmingham
- Investigators
- James Hill, PhD, Principal investigator, University of Alabama at Birmingham
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03832933
- Sponsor's protocol ID
- IRB-300002928
- Status last verified
- May 2022
- First submitted
- 5 Feb 2019
- Last updated
- 10 May 2022
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
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.
PubMed 37475689
Study at a glance
From the registry record, last updated by the sponsor on 10 May 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Comparing High and Normal Protein Diets for the Dietary Remission of Type 2 Diabetes
- ClinicalTrials.gov ID
- NCT03832933
- Acronym / sponsor ID
- IRB-300002928
- Conditions
- Diabetes Type 2, Obesity, Diet Modification
- Keywords
- weight loss, dietary protein
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 117 participants (actual)
- Lead sponsor
- University of Alabama at BirminghamUniversity, hospital or other
- Study start
- 1 Jul 2019 (actual)
- Primary completion
- 22 Apr 2022 (actual)
- Study completion
- 22 Apr 2022 (actual)
- First posted
- 6 Feb 2019 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| High Protein Diet | Experimental | Behavioral: High Protein Diet |
| Standard Protein Diet | Active comparator | Behavioral: Standard Protein Diet |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (7 listed)
- 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)
Key exclusion criteria (10 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| High Protein Diet16 week weight loss and 36 weight loss maintenance intervention. Approximate macronutrient distributions (carbohydrate:protein:fat) will be 32%:40%:28%. | Behavioural | High Protein Diet |
| Standard Protein Diet16 week weight loss and 36 weight loss maintenance intervention. Approximate macronutrient distributions (carbohydrate:protein:fat) will be 53%:21%:25%. | Behavioural | Standard Protein Diet |
Primary outcome
Change in body weight by weight scale
Time frame: Baseline to 16 weeks
Participant body weights will be measured on a kg scale
Change in body weight by weight scale
Time frame: Baseline to 52 weeks
Participant body weights will be measured on a kg scale
5 secondary outcomes
Change in T2D diagnosis criteria
Time frame: Baseline to 52 weeks.
Change in % body fat
Time frame: Baseline to 16 weeks
Change in % body fat
Time frame: Baseline to 52 weeks.
Change in % fat free mass (FFM)
Time frame: Baseline to 16 weeks.
Change in % FFM
Time frame: Baseline to 52 weeks.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 10 May 2022.
- Derived from this study: PubMed 37475689Clina 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.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
James Hill, PhD principal investigator
University of Alabama at Birmingham
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing High Protein Diet and Standard Protein Diet in people with Diabetes Type 2 and Obesity, run by University of Alabama at Birmingham at 2 sites in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 7 inclusion and 10 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 10 May 2022. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change in body weight by weight scale (time frame: Baseline to 16 weeks). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT03832933, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 10 May 2022.