Dapagliflozin Effect on Glucose Variability in Patients Post Bariatric Surgery

Sponsor
Dasman Diabetes Institute
Study ID
NCT07515391
Phase
PHASE2
Status
Enrolling By Invitation

Conditions

  • Bariatric Surgery Candidate
  • Type2 Diabetes

Eligibility Criteria

Sex
ALL
Age
21 Years - 70 Years
Healthy Volunteers
Not accepted

Interventions

  • Dapagliflozin 10 MG — DRUG
    Dapagliflozin 10 mg drug will be administered in both arms for 12 weeks.

Study Details

This study evaluates the effect of SGLT-2 inhibitors (dapagliflozin) on the blood glucose excursions by a continuous glucose monitoring system, the incidence of hypoglycemia and hyperglycemia and change in glycated hemoglobin (HbA1c) level in people had bariatric surgery with and without type 2 diabetes.

Key Dates

Start date
Oct 22, 2019
Status verified
Mar 2026
Primary completion
May 1, 2021
Completion
Oct 22, 2026

Study Design

Enrollment
30 participants (estimated)
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
PREVENTION

Arms

  • Active Comparator: (1) People with type 2 diabetes with post-bariatric surgery
  • Active Comparator: (2) people without diabetes with post-bariatric surgery.

Primary Outcome Measure

Time spent below 3 mmol/L and above 10 mmol/L on and off dapagliflozin [ Time Frame: 12 weeks ]

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