Prevention of Metabolic Complications of Glucocorticoid Excess
|The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.|
|ClinicalTrials.gov Identifier: NCT01319994|
Recruitment Status : Unknown
Verified July 2012 by Marta Korbonits, Barts & The London NHS Trust.
Recruitment status was: Recruiting
First Posted : March 22, 2011
Last Update Posted : July 26, 2012
|Condition or disease||Intervention/treatment||Phase|
|Glucocorticoid Treatment||Drug: Metformin Drug: Placebo||Phase 2 Phase 3|
2 Study Aims and Objectives To investigate the effect of metformin treatment on metabolic parameters in patients with long-term high dose GCs.
3 Study Design 3.1 General Design We will recruit patients (18-75y) with excess glucocorticoids either because they have Cushing's syndrome or they have inflammatory conditions requiring GC treatment (e.g. rheumatoid arthritis, giant cell arteritis/polymyalgia rheumatica) into a pilot, randomised, double-blind, placebo-controlled trial. These patients will be treated with metformin to prevent or reverse their metabolic complications. Prevention algorithm: Patients who are about to start GC treatment predictably for ≥12w at a ≥10mg/d prednisolone (or equivalent) dose who consent to participate in this study will be randomly assigned to receive either placebo (20 patients/group, see power calculations) or metformin at the maximum tolerated dose with a minimum of 850 mg bd for 12w. Treatment algorithm: Consenting patients already on long-term GC treatment (≥4w, ≥20mg/d) who are expected to continue for at least 12w at ≥10mg/d prednisolone will be randomly assigned to receive either placebo or metformin for 12w. In both algorithms, metformin treatment will be started gradually (as standard practice) to avoid gastrointestinal side effects and the full dose will be reached by day 10. Patients will have a full clinical assessment before the start of the metformin treatment and at the end of the 12w treatment period. Anthropometric and biochemical parameters and questionnaires will be repeated at 4 and 8 weeks.
Patients with endogenous Cushing's syndrome will be randomly assigned to receive either placebo (10 patients/group) or metformin at the maximum tolerated dose with a minimum of 850 mg bd for 4 weeks. Patients will have a full clinical assessment before the start of the metformin treatment and at the end of the 4w treatment period.
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||100 participants|
|Intervention Model:||Parallel Assignment|
|Masking:||Triple (Participant, Care Provider, Investigator)|
|Official Title:||Prevention of Metabolic Complications of Glucocorticoid Excess - a Randomised, Doubleblind,Placebo Controlled Study|
|Study Start Date :||September 2010|
|Estimated Primary Completion Date :||January 2015|
|Estimated Study Completion Date :||January 2015|
Placebo Comparator: Placebo
- CT abdomen [ Time Frame: 3 months ]change in liver fat
- HOMA [ Time Frame: 3 months ]This is a measurement of insulin sensitivity
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): NCT01319994
|Barts and the London||Recruiting|
|London, United Kingdom|
|Principal Investigator:||Marta Korbonits, MD, PhD||Barts and The London|