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Note: This record shows only 22 elements of the WHO Trial Registration Data Set. To view changes that have been made to the source record, or for additional information about this trial, click on the URL below to go to the source record in the primary register.

Register:	EUCTR
Last refreshed on:	10 December 2019
Main ID:	EUCTR2008-005708-18-GB
Date of registration:	14/04/2010
Prospective Registration:	Yes
Primary sponsor:	Queen Mary University of London
Public title:	Prevention of metabolic complications of glucocorticoid excess - Prevention of metabolic complications of glucocorticoid excess
Scientific title:	Prevention of metabolic complications of glucocorticoid excess - Prevention of metabolic complications of glucocorticoid excess
Date of first enrolment:	04/06/2010
Target sample size:	100
Recruitment status:	Not Recruiting
URL:	https://www.clinicaltrialsregister.eu/ctr-search/search?query=eudract_number:2008-005708-18
Study type:	Interventional clinical trial of medicinal product
Study design:	Controlled: yes Randomised: yes Open: Single blind: Double blind: yes Parallel group: Cross over: Other: If controlled, specify comparator, Other Medicinial Product: Placebo: yes Other:
Phase:	Human pharmacology (Phase I): no Therapeutic exploratory (Phase II): yes Therapeutic confirmatory - (Phase III): no Therapeutic use (Phase IV): no

Countries of recruitment
United Kingdom

Contacts

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Key inclusion & exclusion criteria

Inclusion criteria:
Inclusion Criteria for patients to be included in the “Prevention” arm
· Patients diagnosed with a rheumatological disease and not started yet on GC treatment
· minimal duration of prospective therapy 12w
· dose of prednisolone =10mg/d (or equivalent GC)
· ambulatory patients
· patients >18 years and · ability to understand verbal and written instructions and informed consent

Inclusion Criteria for patients to be included in the “Treatment” arm
· Patients treated with GC >20mg/d for at least 4wks
· minimal duration of prospective therapy 12w
· dose of prednisolone =10mg/d (or equivalent GC)
· ambulatory patients
· patients >18 years old
· ability to understand verbal and written instructions and informed consent

Inclusion Criteria for patients diagnosed with Cushing’s syndrome
· Patients diagnosed with Cushing’s syndrome
· ambulatory patients
· patients >18 years old
· ability to understand verbal and written instructions and informed consent
·
Exclusion Criteria
· Prior therapy with metformin during the last 6 months
· pre-existing diabetes
· pregnancy
· liver impairment: ALT and/or AST =2.5 x upper normal limit
· renal impairment: serum creatinine levels =135.0 µmol/L in males and =110.0 µmol/L in females
· current malignancy
· patients unable to give written informed consent
· or patients not understanding English and no translation available

Are the trial subjects under 18? no
Number of subjects for this age range:
F.1.2 Adults (18-64 years) yes
F.1.2.1 Number of subjects for this age range
F.1.3 Elderly (>=65 years) yes
F.1.3.1 Number of subjects for this age range

Exclusion criteria:
· Prior therapy with metformin during the last 6 months
· pre-existing diabetes
· pregnancy
· liver impairment: ALT and/or AST =2.5 x UNL
· renal impairment: serum creatinine levels =135.0 µmol/L in males and =110.0 µmol/L in females
· current malignancy
· patients unable to give written informed consent
· or patients not understanding English and no translation available

Age minimum:
Age maximum:
Gender:
Female: yes
Male: yes

Health Condition(s) or Problem(s) studied

Rheumatoid arthritis, SLE, Polymyalgia rheumatica, Disthyroid eye disease, Cushing's syndrome

Intervention(s)

Trade Name: Glucophage (metformin)
Product Name: Metformin
Pharmaceutical Form: Tablet

Primary Outcome(s)

Secondary Objective: To identify various metabolic parameters which might improve with the suggested therapy

Primary end point(s): Change in visceral to subcutaneous fat area ratio as assessed by CT.

Main Objective: This proposal aims to prevent or treat the deleterious metabolic consequences of glucocorticoids in patients with glucocorticoid excess

Secondary Outcome(s)

Secondary ID(s)

14081962

Source(s) of Monetary Support

Secondary Sponsor(s)

Ethics review

Status: Approved
Approval date:
Contact:

Results

Results available:
Date Posted:
Date Completed:
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