Status:

COMPLETED

Return of First-phase Insulin Secretion in Type 2 Diabetes is Associated With Depletion of Pancreas Lipid

Lead Sponsor:

University of Alabama at Birmingham

Conditions:

Type 2 Diabetes Mellitus

Eligibility:

All Genders

35-65 years

Phase:

NA

Brief 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 respon...

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 ...

Eligibility Criteria

Inclusion

  • 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)

Exclusion

  • 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

Key Trial Info

Start Date :

October 9 2018

Trial Type :

INTERVENTIONAL

Allocation :

ACTUAL

End Date :

July 31 2023

Estimated Enrollment :

65 Patients enrolled

Trial Details

Trial ID

NCT03430310

Start Date

October 9 2018

End Date

July 31 2023

Last Update

October 24 2024

Active Locations (1)

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1

The University of Alabama at Birmingham

Birmingham, Alabama, United States, 35294