Metformin to Prevent Metabolic Complications in Glucocorticoid Excess

Patients With Glucocorticoid Treatment Clinical Trial

Official title:

Metformin to Prevent Metabolic Complications in Glucocorticoid Excess

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01187849
• Other study ID #: EKBB 245/09
• Status: Completed
• Phase: Phase 4
• First received: August 23, 2010
• Last updated: April 27, 2016
• Start date: August 2010
• Est. completion date: December 2015

Study information

• Verified date: April 2016
• Source: University Hospital, Basel, Switzerland
• Contact: n/a
• Is FDA regulated: No
• Health authority: Switzerland: SwissmedicSwitzerland: Ethikkommission
• Study type: Interventional

Clinical Trial Summary

The purpose of this study is to evaluate if a treatment with metformin compared to placebo reduces metabolic side-effects in patients with glucocorticoid treatment over three months time.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 29
• Est. completion date: December 2015
• Est. primary completion date: August 2015
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years to 100 Years

Eligibility

Inclusion Criteria:

• Glucocorticoid treatment for = 3 months with a prednisone dose of = 7.5mg/d or equivalent glucocorticoid

Exclusion Criteria:

• Refusal of informed consent

• Prior therapy with metformin during the last 6 month

• Preexisting diabetes

• Pregnancy or current malignancy

• Renal insufficiency with a creatinine clearance lower than 30ml/min

Study Design

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Investigator, Outcomes Assessor), Primary Purpose: Prevention

Related Conditions & MeSH terms

• Patients With Glucocorticoid Treatment

Intervention

Drug:
• Metformin
Volunteers will be given Metformin or placebo for 1 month, once daily.
• Placebo
Volunteers will be given Metformin or placebo for 1 month, once daily

Locations

Country	Name	City	State
Switzerland	University Hospital Basel	Basel	Basel-Stadt

Sponsors (1)

Lead Sponsor	Collaborator
University Hospital, Basel, Switzerland

Country where clinical trial is conducted

Switzerland, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	2 hours glucose level after a standardized 75g oral glucose tolerance test (OGTT)		0 months, 3 months	No
Secondary	homeostasis model assessment (HOMA)-index		0 months, 3 months	No