NCT01187849CompletedPhase 4
Metformin to Prevent Metabolic Complications in Glucocorticoid Excess
University Hospital, Basel, Switzerland1 site in 1 country29 target enrollmentStarted: August 2010Last updated:
Conditions
Interventions
Drugs
Trial Snapshot
- Phase
- Phase 4
- Status
- Completed
- Sponsor
- Enrollment
- 29
- Locations
- 1
- Primary Endpoint
- 2 hours glucose level after a standardized 75g oral glucose tolerance test (OGTT)
Study Overview
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.
Study Design
- Study Type
- Interventional
- Allocation
- Randomized
- Intervention Model
- Parallel
- Primary Purpose
- Prevention
- Masking
- Triple (Participant, Investigator, Outcomes Assessor)
Eligibility Criteria
- Ages
- 18 Years to 100 Years (Adult, Older Adult)
- Sex
- All
- Accepts Healthy Volunteers
- No
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
Arms & Interventions
Metformin
Active Comparator
Intervention: Metformin (Drug)
Placebo
Placebo Comparator
Intervention: Placebo (Drug)
Outcomes
Primary Outcomes
2 hours glucose level after a standardized 75g oral glucose tolerance test (OGTT)
Time Frame: 0 months, 3 months
Secondary Outcomes
- homeostasis model assessment (HOMA)-index(0 months, 3 months)
Investigators
Study Sites (1)
Loading locations...
Similar Trials
Terminated
Phase 4
Effects of Metformin and Fish Oil on Treatment With ClozapineSchizo-affective DisorderSchizophreniaNCT02140788Duke University34
Terminated
Phase 2
Metformin to Mitigate Sequelae of Radioactive Iodine Treatment for Thyroid CancersThyroidNCT03109847Sidney Kimmel Cancer Center at Thomas Jefferson University13
Recruiting
Phase 3
The effect of the metformin in preventing of the preeclampsiaon severe preeclampsia.Mild to moderate pre-eclampsia, unspecified trimesterO14.00IRCT20210316050725N1Iran University of Medical Sciences52
Not yet recruiting
Phase 4
A study to evaluate the role of metformin in preventing the incidence and complications of superimposed pre-eclampsia in chronic hypertensive patientsCTRI/2024/01/061712Thanjavur medical college
Recruiting
Phase 3
Implementation of Metformin theraPy to Ease Decline of Kidney Function in Polycystic Kidney Disease (IMPEDE-PKD)Autosomal Dominant Polycystic Kidney DiseaseNCT04939935The University of Queensland1,174