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Metformin to Prevent Metabolic Complications in Glucocorticoid Excess

This study is currently recruiting participants.
Verified January 2013 by University Hospital, Basel, Switzerland
Sponsor:
Information provided by (Responsible Party):
Mirjam Christ-Crain, University Hospital, Basel, Switzerland
ClinicalTrials.gov Identifier:
NCT01187849
First received: August 23, 2010
Last updated: January 15, 2013
Last verified: January 2013
History of Changes
  Purpose

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.


Condition Intervention Phase
Patients With Glucocorticoid Treatment
 Drug: Metformin
Drug: Placebo
 Phase 4

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Investigator, Outcomes Assessor)
Primary Purpose: Prevention
Official Title: Metformin to Prevent Metabolic Complications in Glucocorticoid Excess

Resource links provided by NLM:

MedlinePlus related topics: Steroids
U.S. FDA Resources

Further study details as provided by University Hospital, Basel, Switzerland:

Primary Outcome Measures:
  • 2 hours glucose level after a standardized 75g OGTT [ Time Frame: 0 months, 3 months ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • HOMA-index [ Time Frame: 0 months, 3 months ] [ Designated as safety issue: No ]

Estimated Enrollment: 66
Study Start Date: August 2010
Estimated Study Completion Date: December 2013
Estimated Primary Completion Date: August 2013 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Active Comparator: Metformin Drug: Metformin
Volunteers will be given Metformin or placebo for 1 month, once daily.
Placebo Comparator: Placebo Drug: Placebo
Volunteers will be given Metformin or placebo for 1 month, once daily

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

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
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01187849

Contacts
Contact: Mirjam Christ-Crain, Prof. Dr. med. 61 265 5078 ext 0041 Mirjam.Christ-Crain@unibas.ch

Locations
Switzerland
University Hospital Basel Recruiting
Basel, Basel-Stadt, Switzerland, 4031
Contact: Mirjam Christ-Crain, Prof. Dr. med.     61 265 5078 ext 0041     Mirjam.Christ-Crain@unibas.ch    
Principal Investigator: Mirjam Christ-Crain, Prof. Dr. med.            
Sponsors and Collaborators
University Hospital, Basel, Switzerland
Investigators
Principal Investigator: Mirjam Christ-Crain, Prof. Dr. med. University Hospital, Basel, Switzerland
  More Information

No publications provided

Responsible Party: Mirjam Christ-Crain, Leitende Aerztin Prof. Dr. med., University Hospital, Basel, Switzerland
ClinicalTrials.gov Identifier: NCT01187849     History of Changes
Other Study ID Numbers: EKBB 245/09
Study First Received: August 23, 2010
Last Updated: January 15, 2013
Health Authority: Switzerland: Swissmedic
Switzerland: Ethikkommission

Additional relevant MeSH terms:
Glucocorticoids
Metformin
Hormones
Hormones, Hormone Substitutes, and Hormone Antagonists
 Physiological Effects of Drugs
Pharmacologic Actions
Hypoglycemic Agents

ClinicalTrials.gov processed this record on May 16, 2013