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Enrolling by Invitation

NCT Number: NCT07515391

Dapagliflozin Effect on Glucose Variability in Patients Post Bariatric Surgery

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.

Enrolling by Invitation

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Key information

Age range

21 year–70 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 2

Primary location

Dasman Diabetes Institute

Kuwait City, Dasman, 15462, Kuwait

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Dapagliflozin 10 mg

Drug

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

Primary outcomes

  1. Time spent below 3 mmol/L and above 10 mmol/L on and off dapagliflozin

    Time frame: 12 weeks

    Time spent below 3 mmol/L and above 10 mmol/L on and off dapagliflozin

Secondary outcomes

  1. Glucose variability, glycemic control (HbA1c)

    Time frame: 12 weeks

    Glucose variability, glycemic control (HbA1c)

  2. Glycemic control (HbA1c)

    Time frame: 12 weeks

    Glycemic control (HbA1c)

  3. change in body weight (Kg)

    Time frame: 12 weeks

    change in body weight (Kg)

  4. change in insulin resistance and beta cell function (HOMA-IR and HOMA-S)

    Time frame: 12 weeks

    change in insulin resistance and beta cell function (HOMA-IR and HOMA-S)

Sponsors and collaborators

Lead sponsor

Dasman Diabetes Institute

Other

Collaborators

  • Kuwait Foundation for the Advancement of Sciences

Registry information

Important dates

Study start
2019
Primary completion
2021
Study completion
2026
First posted
Apr 7, 2026
Registry last updated
Apr 7, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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