Metformin to Prevent Metabolic Complications in Glucocorticoid Excess

NCT ID: NCT01187849

Last Updated: 2016-04-28

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE4

Total Enrollment

29 participants

Study Classification

INTERVENTIONAL

Study Start Date

2010-08-31

Study Completion Date

2015-12-31

Brief Summary

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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.

Detailed Description

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Conditions

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Patients With Glucocorticoid Treatment

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

PREVENTION

Blinding Strategy

TRIPLE

Participants Investigators Outcome Assessors

Study Groups

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Metformin

Group Type ACTIVE_COMPARATOR

Metformin

Intervention Type DRUG

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

Placebo

Group Type PLACEBO_COMPARATOR

Placebo

Intervention Type DRUG

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

Interventions

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Metformin

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

Intervention Type DRUG

Placebo

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

Intervention Type DRUG

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Maximum Eligible Age

100 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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University Hospital, Basel, Switzerland

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Mirjam Christ-Crain, MD, Prof.

Role: PRINCIPAL_INVESTIGATOR

University Hospital, Basel, Switzerland

Locations

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University Hospital Basel

Basel, Canton of Basel-City, Switzerland

Site Status

Countries

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Switzerland

Other Identifiers

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EKBB 245/09

Identifier Type: -

Identifier Source: org_study_id

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