Metformin to Prevent Metabolic Complications in Glucocorticoid Excess

This study is currently recruiting participants. (see Contacts and Locations)
Verified May 2014 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: May 19, 2014
Last verified: May 2014
  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:


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 2015
Estimated Primary Completion Date: August 2015 (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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

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: May 19, 2014
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 July 20, 2014