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

NCT07367555 | Completed Phase 1

• 1 other identifier: 14
• Study Type: interventional
• Target: 360
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Diabete Mellitus

Keywords

Body Mass Index; Glycemic Index; Sodium Glucose Co-transporter-2 Inhibitors

Outcome Measures

Primary Outcomes (1)

• Weight

  Weight is measured in Kilograms

  03 Months

Secondary Outcomes (1)

• Height

  03 months

Study Arms (2)

Group A participants with Type II Diabetes Mellitus

EXPERIMENTAL

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.

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

Group B participants with Type II Diabetes Mellitus

ACTIVE COMPARATOR

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.

Other: Diet plan and exercise

Interventions

Diet plan and exercise OTHER

Only Life style modification was advised. Changes in BMI were assessed.

Group B participants with Type II Diabetes Mellitus

Oral 100 gram Empagliflozin tablet along with diet plan and exercise DRUG

oral 100 gram Empagliflozin tablet along with diet plan and exercise

Group A participants with Type II Diabetes Mellitus

Eligibility Criteria

• Age: 30 Years - 70 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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)

You may not qualify if:

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

Sponsors & Collaborators

• Ariba Shafiq: lead

Study Sites (1)

CMH Multan

Multan, Punjab Province, 60010, Pakistan

Location

MeSH Terms

Conditions

Diabetes Mellitus

Interventions

Exercise

Condition Hierarchy (Ancestors)

Glucose Metabolism Disorders; Metabolic Diseases; Nutritional and Metabolic Diseases; Endocrine System Diseases

Intervention Hierarchy (Ancestors)

Motor Activity; Movement; Musculoskeletal Physiological Phenomena; Musculoskeletal and Neural Physiological Phenomena

Study Officials

• Professor Dr Khalid Mehmood Raja, MBBS FCPS

  CMH Multan

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: PARTICIPANT
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: Principal Investigator

Study Record Dates

• First Submitted: January 18, 2026
• First Posted: January 26, 2026
• Study Start: October 1, 2024
• Primary Completion: March 31, 2025
• Study Completion: March 31, 2025
• Last Updated: January 26, 2026

Record last verified: 2026-01

Data Sharing

• IPD Sharing: Will not share

Locations

PA (1)