Bariatric Surgery Candidate, Type2 Diabetes
Conditions
Keywords
SGLT-2, Bariatric Surgery, Type 2 diabetes, Glucose variability
Brief summary
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
DRUGDapagliflozin 10 MG
Dapagliflozin 10 mg drug will be administered in both arms for 12 weeks.
Sponsors
Dasman Diabetes Institute
Kuwait Foundation for the Advancement of Sciences
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
PREVENTION
Masking
QUADRUPLE (Subject, Caregiver, Investigator, Outcomes Assessor)
Intervention model description
This study has two groups (1) People with type 2 diabetes with post-bariatric surgery, (2) people without diabetes with post-bariatric surgery.
Eligibility
Sex/Gender
ALL
Age
21 Years to 70 Years
Healthy volunteers
No
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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Time spent below 3 mmol/L and above 10 mmol/L on and off dapagliflozin | 12 weeks | Time spent below 3 mmol/L and above 10 mmol/L on and off dapagliflozin |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Glucose variability, glycemic control (HbA1c) | 12 weeks | Glucose variability, glycemic control (HbA1c) |
| Glycemic control (HbA1c) | 12 weeks | Glycemic control (HbA1c) |
| change in body weight (Kg) | 12 weeks | change in body weight (Kg) |
| change in insulin resistance and beta cell function (HOMA-IR and HOMA-S) | 12 weeks | change in insulin resistance and beta cell function (HOMA-IR and HOMA-S) |
Countries
Kuwait
Outcome results
None listed