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Metformin to Prevent Metabolic Complications in Glucocorticoid Excess

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ClinicalTrials.gov Identifier: NCT01187849
Recruitment Status : Completed
First Posted : August 24, 2010
Last Update Posted : April 28, 2016
Sponsor:
Information provided by (Responsible Party):
University Hospital, Basel, Switzerland

Brief 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.

Condition or disease Intervention/treatment Phase
Patients With Glucocorticoid Treatment Drug: Metformin Drug: Placebo Phase 4

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 29 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Triple (Participant, Investigator, Outcomes Assessor)
Primary Purpose: Prevention
Official Title: Metformin to Prevent Metabolic Complications in Glucocorticoid Excess
Study Start Date : August 2010
Actual Primary Completion Date : August 2015
Actual Study Completion Date : December 2015

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Steroids

Arm Intervention/treatment
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




Primary Outcome Measures :
  1. 2 hours glucose level after a standardized 75g oral glucose tolerance test (OGTT) [ Time Frame: 0 months, 3 months ]

Secondary Outcome Measures :
  1. homeostasis model assessment (HOMA)-index [ Time Frame: 0 months, 3 months ]


Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 100 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01187849


Locations
Switzerland
University Hospital Basel
Basel, Basel-Stadt, Switzerland, 4031
Sponsors and Collaborators
University Hospital, Basel, Switzerland
Investigators
Principal Investigator: Mirjam Christ-Crain, MD, Prof. University Hospital, Basel, Switzerland

Responsible Party: University Hospital, Basel, Switzerland
ClinicalTrials.gov Identifier: NCT01187849     History of Changes
Other Study ID Numbers: EKBB 245/09
First Posted: August 24, 2010    Key Record Dates
Last Update Posted: April 28, 2016
Last Verified: April 2016
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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