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OpenTrials
Completed

NCT Number: NCT01187849

Metformin to Prevent Metabolic Complications in Glucocorticoid Excess

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.

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Key information

Conditions

Patients With Glucocorticoid Treatment

Age range

18 year–100 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 4

Primary location

University Hospital Basel

Basel, Canton of Basel-City, 4031, Switzerland

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

metformin

Drug

Volunteers will be given Metformin or placebo for 1 month, once daily.

Placebo

Drug

Volunteers will be given Metformin or placebo for 1 month, once daily

Primary outcomes

  1. 2 hours glucose level after a standardized 75g oral glucose tolerance test (OGTT)

    Time frame: 0 months, 3 months

Secondary outcomes

  1. homeostasis model assessment (HOMA)-index

    Time frame: 0 months, 3 months

Sponsors and collaborators

Lead sponsor

University Hospital, Basel, Switzerland

Other

Registry information

Important dates

Study start
2010
Primary completion
2015
Study completion
2015
First posted
Aug 24, 2010
Registry last updated
Apr 28, 2016

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.