Glucocorticoid Effect Clinical Trial
— Gluco-MetOfficial title:
Counteracting Deleterious Metabolic Glucocorticoid Effects With Metformin - A Double-blind, Randomized, Placebo-controlled, Cross-over Study
Verified date | September 2021 |
Source | University Hospital, Basel, Switzerland |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Interventional |
Supraphysiological doses of glucocorticoids (GCs) are widely prescribed as immunosuppressants and metabolic side effects such as obesity and diabetes are extremely common. Efforts to investigate and prevent these side effects are lacking. The antidiabetic drug metformin was shown in previous studies to prevent deterioration of glucose homeostasis during GC therapy in patients. However, mechanisms of metformin counteracting GC-induced side effects remain poorly understood. In a randomized, placebo-controlled, cross-over study, 18 healthy volunteers will receive a 7-day course of prednisone with metformin or placebo. Established methods will be used to assess systemic changes in energy homeostasis and novel techniques such as metabolomics will identify underlying pathways. This will advance the understanding of energy homeostasis during GC excess, may prevent thousands of patients from GC-induced side effects and also offers a model for targeting disrupted endogenous GCs secretion.
Status | Completed |
Enrollment | 19 |
Est. completion date | August 18, 2021 |
Est. primary completion date | August 18, 2021 |
Accepts healthy volunteers | Accepts Healthy Volunteers |
Gender | Male |
Age group | 18 Years to 40 Years |
Eligibility | Inclusion Criteria: - BMI 18.5 - 25 kg/m2 Exclusion Criteria: - Any current significant disease, - Any medication - Glucocorticoids and/ or metformin for up to four weeks before study inclusion - Regular alcohol intake (>30g/d), - Regular physical activity (>4hrs per week), - Known allergy to metformin, - Inability or unwillingness to provide informed consent. |
Country | Name | City | State |
---|---|---|---|
Switzerland | University Hospital Basel | Basel | Basel-Stadt |
Lead Sponsor | Collaborator |
---|---|
Eleonora Seelig |
Switzerland,
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Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Other | Metabolomics | Metabolomics will be performed in blood plasma | Two 1-week intervention periods | |
Other | Gene expression analysis | Adipose tissue biobsy | Two 1-week intervention periods | |
Primary | Insulin sensitivity | Change in insulin sensitivity (HOMA-Index) assessed with a mixed meal tolerance test. | Two 1-week intervention periods | |
Secondary | Lipids (mmol/l) | Blood sample | Two 1-week intervention periods | |
Secondary | Cortisol (nmol/l) | Blood sample | Two 1-week intervention periods | |
Secondary | GLP-1 (nmol/l) | Blood sample | Two 1-week intervention periods | |
Secondary | GIP (nmol/l) | Blood sample | Two 1-week intervention periods | |
Secondary | PYY (pg/ml) | Blood sample | Two 1-week intervention periods | |
Secondary | C-peptide (pmol/l) | Blood sample | Two 1-week intervention periods | |
Secondary | T3 (nmol/l) | Blood sample | Two 1-week intervention periods | |
Secondary | T4 (nmol/l) | Blood sample | Two 1-week intervention periods | |
Secondary | TSH (mIU/l) | Blood sample | Two 1-week intervention periods | |
Secondary | HGH (mIU/l) | Blood sample | Two 1-week intervention periods | |
Secondary | Sympathetic nervous system activity | Heart rate variability analysis | Two 1-week intervention periods | |
Secondary | Blood pressure | Assessment of blood pressure with a standard blood pressure monitor. | Two 1-week intervention periods | |
Secondary | Weight | Measurement of weight with a standard scale | Two 1-week intervention periods | |
Secondary | Energy expenditure | Basal metabolic rate measured with indirect calorimetry | Two 1-week intervention periods | |
Secondary | Substrate utilisation | Respiratory quotient assessed with indirect calorimetry | Two 1-week intervention periods | |
Secondary | GDF-15 (pg/mL) | Blood sample | Two 1-week intervention periods |
Status | Clinical Trial | Phase | |
---|---|---|---|
Recruiting |
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