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| Name | Class |
|---|---|
| Kuwait Foundation for the Advancement of Sciences | UNKNOWN |
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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| (1) People with type 2 diabetes with post-bariatric surgery | Active Comparator |
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| (2) people without diabetes with post-bariatric surgery. | Active Comparator |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Dapagliflozin 10 MG | Drug | Dapagliflozin 10 mg drug will be administered in both arms for 12 weeks. |
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| 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 |
| Measure | Description | Time Frame |
|---|---|---|
| Glucose variability, glycemic control (HbA1c) | Glucose variability, glycemic control (HbA1c) | 12 weeks |
| Glycemic control (HbA1c) | Glycemic control (HbA1c) |
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Exclusion Criteria:
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Dasman Diabetes Institute | Kuwait City | Dasman | 15462 | Kuwait |
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| ID | Term |
|---|---|
| D003924 | Diabetes Mellitus, Type 2 |
| ID | Term |
|---|---|
| D003920 | Diabetes Mellitus |
| D044882 | Glucose Metabolism Disorders |
| D008659 | Metabolic Diseases |
| D009750 | Nutritional and Metabolic Diseases |
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| ID | Term |
|---|---|
| C529054 | dapagliflozin |
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This study has two groups (1) People with type 2 diabetes with post-bariatric surgery, (2) people without diabetes with post-bariatric surgery.
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| 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 |
| D004700 | Endocrine System Diseases |