Dapagliflozin Effect on Glucose Variability in Patients Post Bariatric Surgery

Phase 2Enrolling By InvitationNCT07515391

Dasman Diabetes Institute30 enrolled

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.

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

Allocation

RANDOMIZED

Purpose

PREVENTION

Masking

QUADRUPLE

Enrollment

Conditions

Bariatric Surgery Candidate Type2 Diabetes

Interventions

Dapagliflozin 10 MGDRUG

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

Eligibility

Sex: ALLMin age: 21 YearsMax age: 70 Years

Medical Language ↔ Plain English

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.

Locations (1)

Dasman Diabetes Institute

Kuwait City, Dasman, Kuwait

Outcomes

Primary Outcomes

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

Time frame: 12 weeks

Secondary Outcomes

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

Data from ClinicalTrials.gov

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