Effect Of Sodium Glucose Co-Transporter-2 (SGLT-2) Inhibitors on Body Mass Index After 3 Months of Use in Diabetic Patients

Ariba Shafiq

Status and phase: Completed; Phase 1

Conditions: Diabete Mellitus

Treatments: Drug: Oral 100 gram Empagliflozin tablet along with diet plan and exercise; Other: Diet plan and exercise

Study type: Interventional

Funder types: Other

Identifiers

NCT07367555

14

Details and patient eligibility

About

Total of 360 participants were enrolled and prescribed oral 200 mg SGLT-2 tablet. All participants were followed-up for about three months. Body mass index was measured before and after three months and mean change in BMI was assessed.

Enrollment: 360 patients

Sex: All

Ages: 30 to 70 years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• Individuals diagnosed with type II diabetes mellitus ( blood sugar level (random) at presentation was above 186 mg/dl and HbA1c was more than 6.5% on laboratory investigations)

Exclusion criteria

• Individuals already taking trail drug or any other anti-glycemic drug or insulin for >6 months

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Single Blind

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360 participants in 2 patient groups

Group A participants with Type II Diabetes Mellitus

Experimental group

Description:

Randomly 180 Individuals with diagnosed type 2 Diabetes Mellitus were allocated group A. These individuals were prescribed oral 100 gram Empagliflozin tablet along with diet plan and exercise. All individuals were followed-up in OPD for 3 months. After 3 months, individuals were assessed again for height, weight, and BMI. Changes in weight and BMI were calculated.

Treatment:

Drug: Oral 100 gram Empagliflozin tablet along with diet plan and exercise

Group B participants with Type II Diabetes Mellitus

Active Comparator group

Description:

Randomly 180 Individuals with diagnosed type 2 Diabetes Mellitus were allocated group A. These individuals were prescribed oral 100 gram Empagliflozin tablet along with diet plan and exercise. All individuals were followed-up in OPD for 3 months. After 3 months, individuals were assessed again for height, weight, and BMI. Changes in weight and BMI were calculated.

Treatment:

Other: Diet plan and exercise