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.

Study Overview

• Status: Enrolling by invitation
• Conditions: Bariatric Surgery Candidate; Type2 Diabetes
• Intervention / Treatment: Drug: Dapagliflozin 10 MG

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.

• Study Type: Interventional
• Enrollment (Estimated): 30
• Phase: Phase 2

Contacts and Locations

Study Locations

• Kuwait
  • Dasman
    • Kuwait City, Dasman, Kuwait, 15462
      • Dasman Diabetes Institute

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

Description

Inclusion Criteria:

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

Exclusion Criteria:

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Prevention
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Quadruple

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Active Comparator: (1) People with type 2 diabetes with post-bariatric surgery	Drug: Dapagliflozin 10 MG; Dapagliflozin 10 mg drug will be administered in both arms for 12 weeks.
Active Comparator: (2) people without diabetes with post-bariatric surgery.	Drug: Dapagliflozin 10 MG; Dapagliflozin 10 mg drug will be administered in both arms for 12 weeks.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Time spent below 3 mmol/L and above 10 mmol/L on and off dapagliflozin	Time spent below 3 mmol/L and above 10 mmol/L on and off dapagliflozin	12 weeks

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Glucose variability, glycemic control (HbA1c)	Glucose variability, glycemic control (HbA1c)	12 weeks
Glycemic control (HbA1c)	Glycemic control (HbA1c)	12 weeks
change in body weight (Kg)	change in body weight (Kg)	12 weeks
change in insulin resistance and beta cell function (HOMA-IR and HOMA-S)	change in insulin resistance and beta cell function (HOMA-IR and HOMA-S)	12 weeks

Collaborators and Investigators

• Sponsor: Dasman Diabetes Institute
• Collaborators: Kuwait Foundation for the Advancement of Sciences

Study record dates

Study Major Dates

• Study Start (Actual): October 22, 2019
• Primary Completion (Actual): May 1, 2021
• Study Completion (Estimated): October 22, 2026

Study Registration Dates

• First Submitted: December 11, 2019
• First Submitted That Met QC Criteria: March 30, 2026
• First Posted (Actual): April 7, 2026

Study Record Updates

• Last Update Posted (Actual): April 7, 2026
• Last Update Submitted That Met QC Criteria: March 30, 2026
• Last Verified: March 1, 2026

More Information

Terms related to this study

• Keywords: Type 2 diabetes; Bariatric Surgery; Glucose variability; SGLT-2
• Additional Relevant MeSH Terms: Endocrine System Diseases; Metabolic Diseases; Glucose Metabolism Disorders; Diabetes Mellitus; Nutritional and Metabolic Diseases; Diabetes Mellitus, Type 2; dapagliflozin
• Other Study ID Numbers: RA HM 2019-023

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No