N/A
N=65
Return of First-phase Insulin Secretion in Type 2 Diabetes is Associated With Depletion of Pancreas Lipid
Type 2 Diabetes Mellitus
Bottom Line
View on ClinicalTrials.gov: NCT03430310 ↗Enrolled (actual)
65
Serious AEs
0.0%
Results posted
Oct 2024
Primary outcome: Primary: Changes in Liver Fat — 5.4; 7.3 percent liver fat — p=0.05
Study Design & Population
- Study type
- Interventional
- Phase
- N/A
- Interventions
- Low Glycemic Diet (Other); Control Diet (Other)
- Age
- Adult, Older Adult · 35+ yrs
- Sex
- All
- Sponsor
- University of Alabama at Birmingham
- Primary completion
- Jul 2023
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Changes in Liver Fat |
5.4; 7.3 | 0.05 |
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. 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.
Eligibility Criteria
Inclusion Criteria
- 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 2.5-fold above the normal upper limit
- Tobacco or recreational drug use
- Unable to undergo MRI
Data sourced from ClinicalTrials.gov (NCT03430310). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.