Comparison Of Metformin And Exercise On Insulin Resistance In Women With Polycystic Ovary Syndrome

Not yet recruiting

Conditions: Endocrine disorder, unspecified,

Registration Number: CTRI/2020/10/028473

Lead Sponsor: Post Graduate Institute Of Medical Education And Research

Brief Summary: This is a randomized control trial aimed to compare the effect of metformin and moderate intensity exercise on insulin resistance in patients with PCOS.

Women between 18-40 years of age who are overweight/obese shall be included for the study after considering the exclusion criteria.

At baseline, anthropometry, body composition, hormonal profile and metabolic parameters would be recorded and hyperinsulinemic-euglycemic clamp would be done

Thereafter the participants would be randomised into metformin and the exercise group.

A 2 week run in period shall be given to the participants to acclimatise to the exercise program and tolerance to metformin shall be assessed.

The patients shall be followed at 0, 2 and 4 months.

Compliance to the intervention shall be ensured with telephonic calls.

At 4 months, metabolic. hormonal profile shall be repeated along with hyperinsulinemic-euglycemic clamp to assess the change in insulin resistance.

12 Healthy, age and BMI matched controls will be taken and a hyperinsulinemic euglycemic clamp would be performed at baseline for comparison.

Detailed Description: Not available

Recruitment & Eligibility

Status: Not Yet Recruiting

Sex: Female

Target Recruitment: 12

Inclusion Criteria

overweight/obese PCOS women based on Asian BMI classification.

Exclusion Criteria

Diabetes Mellitus Bleeding Disorders Hepatic or renal insufficiency Acute Infection Chronic Disorders Use of oral contraceptives/ hormone replacement therapy/insulin sensitizers within the past six weeks PREGNANCY H/O CAD/CVA/VTE SMOKING.

Study & Design

Study Type: Interventional

Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Effect on insulin resistance	4 months

Secondary Outcome Measures

Name	Time	Method
Alterations In Body Mass Index, HOMA -IR, Luteinizing hormone, Follicle stimulating hormone,Testosterone	4 Months

Trial Locations

Locations (1): Post Graduate Institute Of Medical Education And Research, Chandigarh
🇮🇳
Chandigarh, CHANDIGARH, India
Post Graduate Institute Of Medical Education And Research, Chandigarh
🇮🇳Chandigarh, CHANDIGARH, India
Jasmeet Kaur Bhalla
Principal investigator
9876327236
jaskaurbhalla@gmail.com