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A clinical trial to study the role of metformin in prevention of steroid induced high blood sugars

Metformin for prevention of glucocorticoid induced hyperglycemia in non-diabetic patients: A randomized, parallel-arm, double-blinded, placebo-controlled study - METSHIP

Status
Active, not recruiting
Phases
Unknown
Study type
Interventional
Source
CTRI
Registry ID
CTRI/2020/09/028035
Enrollment
72
Registered
2020-09-24
Start date
Unknown
Completion date
Unknown
Last updated
2021-11-24

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Health Condition 1: D59- Acquired hemolytic anemia Health Condition 2: L10-L14- Bullous disorders Health Condition 3: L20-L30- Dermatitis and eczema Health Condition 4: L60-L75- Disorders of skin appendages Health Condition 5: N00-N08- Glomerular diseases Health Condition 6: M05-M14- Inflammatory polyarthropathies Health Condition 7: L80-L99- Other disorders of the skin and subcutaneous tissue Health Condition 8: M35- Other systemic involvement of connective tissue Health Condition 9: L40-L45- P

Interventions

Intervention1: Metformin: Metformin 500 mg tablet once daily for one week followed by twice daily for the second week and thrice daily from the third week onward till twelve weeks Control Intervention

Sponsors

JIPMER
Lead Sponsor

Eligibility

Inclusion criteria

Inclusion criteria: 1)Non-diabetic, steroid-naive patients or receiving a dose of less than or equal to 5 mg prednisolone equivalent per day and being started on oral glucocorticoids of more than or equal to 20 mg prednisolone or an equivalent dose of another glucocorticoid per day 2)Planned maintenance dose of glucocorticoids after tapering will be more than or equal to 7.5 mg prednisolone or an equivalent dose of other glucocorticoid per day for at least 12 weeks

Exclusion criteria

Exclusion criteria: 1)Preexisting diabetes mellitus 2)Patients receiving intravenous glucocorticoids 3)Renal insufficiency(estimated glomerular filtration rate less than 60ml/min/1.73m2) 4) Deranged liver function tests (Alanine transaminase and aspartate transaminase more than 2.5 times upper limit of normal) 5) Any chronic illness like chronic infection, chronic heart failure, malignancy, etc. 6) Pregnancy and lactation 7) Current alcohol intake of more than 20g per day for males and more than 10g per day for females or substance use

Design outcomes

Primary

MeasureTime frame
The proportion of patients dysglycemiaTimepoint: baseline and three months

Secondary

MeasureTime frame
Area under curve blood glucoseTimepoint: baseline and three months;Body compositionTimepoint: baseline and three months;Homeostatic model assessment(HOMA) indicesTimepoint: baseline and three months;Lipid profileTimepoint: baseline and three months

Countries

India

Contacts

Public ContactDr Jayaprakash Sahoo

JIPMER

drnaik2000@gmail.com9843671306

Outcome results

None listed

Source: CTRI (via WHO ICTRP) · Data processed: Feb 4, 2026