Menu
Enrolling by invitation NCT07515391

Dapagliflozin Effect on Glucose Variability in Patients Post Bariatric Surgery

Phase II Interventional Bariatric Surgery Candidate Type2 Diabetes

For patients and families

In plain language

An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.

What is being studied
The protocol lists: Dapagliflozin 10 MG.
Who it may be relevant to
Registry conditions: Bariatric Surgery Candidate, Type2 Diabetes. Basic parameters: 21 years — 70 years · All.
What needs checking
Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
Where it takes place
Kuwait
Next step
Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →

Unsure about the terms? Read our patient guide →

Overview

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.

Detailed description

Dapagliflozin is a highly selective sodium-glucose transporter 2 (SGLT2) inhibitor, an approved drug for the treatment of type 2 diabetes. It leads to urinary glucose excretion and a reduction of weight. This results in a reduction of both fasting and postprandial glucose levels. This is reported that the treatment of type 2 diabetes with dapagliflozin carries a low risk of hypoglycaemia and have a beneficial effect on weight and blood pressure.

This study hypothesized that bariatric surgery is effective for weight loss. But some patients experience large changes in the blood glucose after meals that lead to hyper and hypoglycaemia and weight regain. This study propose that the use of SGLT-2 inhibitors, which lower glucose and body weight by promoting its renal excretion, will reduce glucose variability in patients after bariatric surgery.

Interventions

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

Primary outcome measures

  • Time spent below 3 mmol/L and above 10 mmol/L on and off dapagliflozin [Time frame: 12 weeks]
Secondary outcome measures (4)
  • Glucose variability, glycemic control (HbA1c) [Time frame: 12 weeks]
  • Glycemic control (HbA1c) [Time frame: 12 weeks]
  • change in body weight (Kg) [Time frame: 12 weeks]
  • change in insulin resistance and beta cell function (HOMA-IR and HOMA-S) [Time frame: 12 weeks]

Eligibility criteria

Inclusion criteria

  • People diagnosed with type 2 diabetes prior to bariatric surgery.
  • People did not have diabetes prior to bariatric surgery.
  • Willing to participate in this study.

Exclusion criteria

  • Type 1 diabetes
  • Secondary diabetes
  • History of ketoacidosis
  • History of pancreatitis and pancreatectomy.
  • History of primary renal glycosuria or hereditary glucose-galactose malabsorption.
  • Active diabetes complications, nephropathy (dipstick positive proteinuria, or reduced eGFR (<60 ml/min), proliferative retinopathy.
  • Clinically significant abnormal liver function test.
  • Pregnant ladies, or intending pregnancy or breastfeeding.
  • Patients using insulin therapy or a sulfonylurea.
  • Uncontrolled hypertension.
  • Uncontrolled thyroid disease.
  • Any history of serious hypertension reaction to the dapagliflozin or SGLT-2 inhibitor.
  • History of malignancy within 5-year of screening.
  • Presence of any other medical condition that would in the opinion of the investigator, preclude safe participation in the study.
  • HbA1c >10.5
  • Unable to sign the consent form.

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: No

Study design

Allocation
Randomized
Model
Parallel assignment
Masking
Quadruple blind
Primary purpose
Prevention

Study locations

Kuwait · 1 center
  • Dasman Diabetes Institute — Kuwait City

Identifiers

NCT: NCT07515391 · RA HM 2019-023

Primary sources (government registries)

View this study on ClinicalTrials.gov ↗