Type 2 Diabetes MellitusNCT03430310
Return of First-phase Insulin Secretion in Type 2 Diabetes is Associated With Depletion of Pancreas Lipid
A study testing Low Glycemic Diet in people with Type 2 Diabetes Mellitus, run by University of Alabama at Birmingham at 1 site in United States.
Trial summary
The hypothesis for this study is that pancreas lipid will be more closely associated with first-phase beta-cell response in African-Americans than in European-Americans, both at baseline and in response to treatment. Read more about this study
- Who is it for?
- Ages 35 to 65 yearsHealthy volunteers can take part
- Conditions the study is for
- Type 2 Diabetes Mellitus
- What is being tested?
- Low Glycemic Diet
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 65 participants
- Where
- 1 siteUnited States
- Study dates
- 9 Oct 2018to 31 Jul 2023
- Phase
- Interventional
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
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 35 to 65 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Diagnosed with Type 2 Diabetes within the past 10 years
- Treated with diet, Metformin, or dipeptidyl peptidase 4 (DPP-IV) inhibitors
- Adult men and women age 35-65 yr
- Have a Hemoglobin A1c <7.0
- African American or European American race
- Will be overweight (BMI 25-45 kg/m2) but have a stable BMI (<5 kg change in the past 6 months)
Who cannot join
- Use of glucocorticoids
- Estimated glomerular filtration rate <60
- Alanine aminotransferase >2.5-fold above the normal upper limit
- Tobacco or recreational drug use
- Unable to undergo MRI
Trial locations and contacts
1 site in 1 country.
United States1 site
The University of Alabama at Birmingham
Birmingham, Alabama, 35294
About this study
The hypothesis for this study is that pancreas lipid will be more closely associated with first-phase beta-cell response in African-Americans than in European-Americans, both at baseline and in response to treatment. The investigators will determine whether race influences the association of pancreas lipid with beta-cell function.The proposed research builds upon the investigators preliminary observations in non-diabetic adults that reduction in dietary glycemic load, in the absence of weight loss, selectively reduces visceral adipose tissue and ectopic lipid, and is associated with improvements in insulin sensitivity and beta-cell function. No study has attempted to test the hypothesis that selective reduction in pancreatic lipid with a simple change in diet composition, in the absence of energy restriction, will lead to the recovery of beta-cell function in patients with early Type 2 Diabetes (T2D). The investigators hypothesize that participants following a Low Glycemic Diet will show a greater decrease in pancreas lipid. Specifically, the investigators will be the first to demonstrate that a weight-maintaining low-glycemic diet improves glucose tolerance by increasing first-phase insulin secretion. Results may be particularly relevant to African-Americans who are at greater risk for T2D.
Read the detailed description
The decline in first-phase insulin secretion is a key event in the etiology of type 2 diabetes (T2D). Although the cause of beta-cell failure is not clear, "lipotoxicity" has been proposed. Bariatric surgery and very-low calorie diets in patients with T2D induce disease remission, characterized by a return of first-phase insulin secretion and a depletion of pancreas lipid. However, these are extreme approaches to treating T2D, and non-invasive, sustainable, yet equally effective, treatments are needed. The investigators have shown in individuals at risk for T2D that an intervention with a weight-maintaining low-glycemic (LG) diet selectively depletes visceral adipose tissue and ectopic lipid in muscle while preserving thigh subcutaneous adipose and lean body mass. This observation suggests that such diets are able to "remodel" body composition by re-partitioning energy away from metabolically harmful lipid stores. Participants on the LG diet also demonstrated improved insulin sensitivity and a dramatic (9-fold) increase in first-phase insulin secretion. Thus, the investigators hypothesize that a weight-maintaining LG diet will selectively deplete ectopic adipose tissue, including pancreatic lipid, and will permit recovery of beta-cell function in individuals with T2D. Rescue of beta-cell function may be particularly important in African-Americans (AA), who as a group demonstrate a high prevalence of T2D, for reasons that cannot be explained by lifestyle. AA are likely to be vulnerable to beta-cell failure due to inherently high beta-cell responsiveness (demonstrable in healthy young children). Further, it has been shown that pancreas lipid is a determinant of prediabetes specifically in AA. Thus, the investigators hypothesize that an LG diet will be particularly beneficial to beta-cell function and glycemic control among AA.
- Conditions
- Type 2 Diabetes Mellitus
- Being tested
- Low Glycemic Diet, Control Diet
- Medical subject headings
- Diabetes Mellitus, Type 2
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Low Glycemic DietOther
The investigators will use a Low Glycemic Load Diet (LG Diet), which emphasizes low-glycemic sources of carbohydrate, and includes mainly whole foods (vegetables, fruits, whole grains) with minimal highly processed grain products and added sugar. Protein foods will include meat, poultry, fish, eggs, and whey protein supplements if necessary (e.g., for vegetarians). Fat-containing foods will include olive, coconut, and nut oils; butter; tree nuts and nut butters; cheese; cream; coconut milk; avocados; and the fat found in meat. A number of full-fat dairy products will be included. Saturated fat from red meat will be limited to less than 10% of daily caloric intake. The participants will obtain the majority of their fat intake from mono-unsaturated fatty acids (e.g. olive oil), and medium-chain triglycerides (e.g., coconut oil and cream); from nuts and nut butters; and from fresh fish.
Control DietOther
The Control diet will be compatible with both the American Diabetes Association and The United States Department of Agriculture guidelines. Participants will be given low-fat foods, whole-grain foods, fruits, and vegetables. The meal plans will minimize cholesterol, high-fat foods, high-cholesterol foods, processed starches, and added sugar, and will provide <2300 mg/day sodium. Saturated fat will be limited to less than 10% of total energy, and all dairy products will be fat-free (or low-fat). Although the Control diet will be a healthful diet, it will include a greater amount of carbohydrate foods from such sources as bread, potatoes, and pasta that will distinguish it qualitatively from the LG diet. In addition, it will have quantitatively more total energy from carbohydrate than the LG diet.
| Study group | Role | What they receive |
|---|---|---|
| Low Glycemic Diet | Experimental | The investigators will use a Low Glycemic Load Diet (LG Diet), which emphasizes low-glycemic sources of carbohydrate, and includes mainly whole foods (vegetables, fruits, whole grains) with minimal highly processed grain products and added sugar. Protein foods will include meat, poultry, fish, eggs, and whey protein supplements if necessary (e.g., for vegetarians). Fat-containing foods will include olive, coconut, and nut oils; butter; tree nuts and nut butters; cheese; cream; coconut milk; avocados; and the fat found in meat. A number of full-fat dairy products will be included. Saturated fat from red meat will be limited to less than 10% of daily caloric intake. Participants will obtain the majority of their fat intake from mono-unsaturated fatty acids (e.g. olive oil), and medium-chain triglycerides (e.g., coconut oil and cream); from nuts and nut butters; and from fresh fish. Receives: Other: Low Glycemic Diet |
| Control Diet | Placebo comparator | The Control diet will be compatible with both the American Diabetes Association and The United States Department of Agriculture guidelines. Participants will be given low-fat foods, whole-grain foods, fruits, and vegetables. The meal plans will minimize cholesterol, high-fat foods, high-cholesterol foods, processed starches, and added sugar, and will provide <2300 mg/day sodium. Saturated fat will be limited to less than 10% of total energy, and all dairy products will be fat-free (or low-fat). Although the Control diet will be a healthful diet, it will include a greater amount of carbohydrate foods from such sources as bread, potatoes, and pasta that will distinguish it qualitatively from the LG diet. In addition, it will have quantitatively more total energy from carbohydrate than the LG diet. Receives: Other: Control Diet |
What is being measured
The primary outcome is the main question the study is designed to answer.
Changes in Liver Fat
Assessing the overall percentage of liver fat with magnetic resonance imaging (MRI) to measure
Measured: Baseline, week 12
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted12 Feb 2018
- Study start9 Oct 2018
- Primary completion31 Jul 2023
- Study completion31 Jul 2023
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Other trials for Type 2 Diabetes MellitusStudies 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
- 65 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Alabama at Birmingham
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Barbara Gower, University of Alabama at Birmingham
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03430310
- Sponsor's protocol ID
- R01DK116726
- Status last verified
- Oct 2024
- First submitted
- 24 Jan 2018
- Last updated
- 24 Oct 2024
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 24 Oct 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Return of First-phase Insulin Secretion in Type 2 Diabetes is Associated With Depletion of Pancreas Lipid
- ClinicalTrials.gov ID
- NCT03430310
- Acronym / sponsor ID
- R01DK116726
- Conditions
- Type 2 Diabetes Mellitus
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 65 participants (actual)
- Lead sponsor
- University of Alabama at BirminghamUniversity, hospital or other
- Study start
- 9 Oct 2018 (actual)
- Primary completion
- 31 Jul 2023 (actual)
- Study completion
- 31 Jul 2023 (actual)
- First posted
- 12 Feb 2018 (actual)
- Results
- Posted 24 Oct 2024
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The hypothesis for this study is that pancreas lipid will be more closely associated with first-phase beta-cell response in African-Americans than in European-Americans, both at baseline and in response to treatment. The investigators will determine whether race influences the association of pancreas lipid with beta-cell function.The proposed research builds upon the investigators preliminary observations in non-diabetic adults that reduction in dietary glycemic load, in the absence of weight loss, selectively reduces visceral adipose tissue and ectopic lipid, and is associated with improvements in insulin sensitivity and beta-cell function. No study has attempted to test the hypothesis that selective reduction in pancreatic lipid with a simple change in diet composition, in the absence of energy restriction, will lead to the recovery of beta-cell function in patients with early Type 2 Diabetes (T2D). The investigators hypothesize that participants following a Low Glycemic Diet will show a greater decrease in pancreas lipid. Specifically, the investigators will be the first to demonstrate that a weight-maintaining low-glycemic diet improves glucose tolerance by increasing first-phase insulin secretion. Results may be particularly relevant to African-Americans who are at greater risk for T2D.
Detailed description
The decline in first-phase insulin secretion is a key event in the etiology of type 2 diabetes (T2D). Although the cause of beta-cell failure is not clear, "lipotoxicity" has been proposed. Bariatric surgery and very-low calorie diets in patients with T2D induce disease remission, characterized by a return of first-phase insulin secretion and a depletion of pancreas lipid. However, these are extreme approaches to treating T2D, and non-invasive, sustainable, yet equally effective, treatments are needed. The investigators have shown in individuals at risk for T2D that an intervention with a weight-maintaining low-glycemic (LG) diet selectively depletes visceral adipose tissue and ectopic lipid in muscle while preserving thigh subcutaneous adipose and lean body mass. This observation suggests that such diets are able to "remodel" body composition by re-partitioning energy away from metabolically harmful lipid stores. Participants on the LG diet also demonstrated improved insulin sensitivity and a dramatic (9-fold) increase in first-phase insulin secretion. Thus, the investigators hypothesize that a weight-maintaining LG diet will selectively deplete ectopic adipose tissue, including pancreatic lipid, and will permit recovery of beta-cell function in individuals with T2D. Rescue of beta-cell function may be particularly important in African-Americans (AA), who as a group demonstrate a high prevalence of T2D, for reasons that cannot be explained by lifestyle. AA are likely to be vulnerable to beta-cell failure due to inherently high beta-cell responsiveness (demonstrable in healthy young children). Further, it has been shown that pancreas lipid is a determinant of prediabetes specifically in AA. Thus, the investigators hypothesize that an LG diet will be particularly beneficial to beta-cell function and glycemic control among AA.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Low Glycemic Diet | Experimental | Other: Low Glycemic DietThe investigators will use a Low Glycemic Load Diet (LG Diet), which emphasizes low-glycemic sources of carbohydrate, and includes mainly whole foods (vegetables, fruits, whole grains) with minimal highly processed grain products and added sugar. Protein foods will include meat, poultry, fish, eggs, and whey protein supplements if necessary (e.g., for vegetarians). Fat-containing foods will include olive, coconut, and nut oils; butter; tree nuts and nut butters; cheese; cream; coconut milk; avocados; and the fat found in meat. A number of full-fat dairy products will be included. Saturated fat from red meat will be limited to less than 10% of daily caloric intake. Participants will obtain the majority of their fat intake from mono-unsaturated fatty acids (e.g. olive oil), and medium-chain triglycerides (e.g., coconut oil and cream); from nuts and nut butters; and from fresh fish. |
| Control Diet | Placebo comparator | Other: Control DietThe Control diet will be compatible with both the American Diabetes Association and The United States Department of Agriculture guidelines. Participants will be given low-fat foods, whole-grain foods, fruits, and vegetables. The meal plans will minimize cholesterol, high-fat foods, high-cholesterol foods, processed starches, and added sugar, and will provide <2300 mg/day sodium. Saturated fat will be limited to less than 10% of total energy, and all dairy products will be fat-free (or low-fat). Although the Control diet will be a healthful diet, it will include a greater amount of carbohydrate foods from such sources as bread, potatoes, and pasta that will distinguish it qualitatively from the LG diet. In addition, it will have quantitatively more total energy from carbohydrate than the LG diet. |
Who may qualify
- Ages
- 35 to 65 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- Diagnosed with Type 2 Diabetes within the past 10 years
- Treated with diet, Metformin, or dipeptidyl peptidase 4 (DPP-IV) inhibitors
- Adult men and women age 35-65 yr
- Have a Hemoglobin A1c <7.0
- African American or European American race
Key exclusion criteria (5 listed)
- Use of glucocorticoids
- Estimated glomerular filtration rate <60
- Alanine aminotransferase >2.5-fold above the normal upper limit
- Tobacco or recreational drug use
- Unable to undergo MRI
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 |
|---|---|---|
| Low Glycemic DietThe investigators will use a Low Glycemic Load Diet (LG Diet), which emphasizes low-glycemic sources of carbohydrate, and includes mainly whole foods (vegetables, fruits, whole grains) with minimal highly processed grain products and added sugar. Protein foods will include meat, poultry, fish, eggs, and whey protein supplements if necessary (e.g., for vegetarians). Fat-containing foods will include olive, coconut, and nut oils; butter; tree nuts and nut butters; cheese; cream; coconut milk; avocados; and the fat found in meat. A number of full-fat dairy products will be included. Saturated fat from red meat will be limited to less than 10% of daily caloric intake. The participants will obtain the majority of their fat intake from mono-unsaturated fatty acids (e.g. olive oil), and medium-chain triglycerides (e.g., coconut oil and cream); from nuts and nut butters; and from fresh fish. | Other | Low Glycemic Diet |
| Control DietThe Control diet will be compatible with both the American Diabetes Association and The United States Department of Agriculture guidelines. Participants will be given low-fat foods, whole-grain foods, fruits, and vegetables. The meal plans will minimize cholesterol, high-fat foods, high-cholesterol foods, processed starches, and added sugar, and will provide <2300 mg/day sodium. Saturated fat will be limited to less than 10% of total energy, and all dairy products will be fat-free (or low-fat). Although the Control diet will be a healthful diet, it will include a greater amount of carbohydrate foods from such sources as bread, potatoes, and pasta that will distinguish it qualitatively from the LG diet. In addition, it will have quantitatively more total energy from carbohydrate than the LG diet. | Other | Control Diet |
Primary outcome
Changes in Liver Fat
Time frame: Baseline, week 12
Assessing the overall percentage of liver fat with magnetic resonance imaging (MRI) to measure
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 24 Oct 2024.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
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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.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Low Glycemic Diet in people with Type 2 Diabetes Mellitus, run by University of Alabama at Birmingham at 1 site 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 6 inclusion and 5 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 24 Oct 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site 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. Some participants in this study may receive a placebo. 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?
Yes. Results are posted in the registry (first posted 24 Oct 2024). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
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?
Changes in Liver Fat (time frame: Baseline, week 12). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 24 Oct 2024.