An interventional study of Life style change and weight reduction in Metabolic Syndrome, sponsored by University of Giessen. Status unknown at 1 site in Germany. Open to male participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2021-11-11.
Sponsored by University of Giessen · Not applicable, Interventional, and Health services research
Men diagnosed with metabolic syndrome (MetS) including obesity, hypertension, dyslipidemia and infertility will be assessed for cardiovascular and diabetes risk. The eligible patient will be randomised to one-year life-style intervention program including nutritional, behavioural and exercise counselling or standard care by the general physician. The aim of the program is to reduce cardiovascular and diabetes risks and hypogonadism as well.
2,011 studies on the registry are indexed under Metabolic Syndrome; 334 are open to participants now.
This study's planned enrollment of 70 is above the median of 60 across 1,494 interventional studies indexed under Metabolic Syndrome.
Browse Metabolic Syndrome studies →University of Giessen is the lead sponsor of 95 studies on the registry; 22 are open to participants now.
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Exclusion Criteria:
The intensive treatment group will pass a life-style intervention program including consequent escalation of measures to reach sustained reduction of 10% of initial body weight at minimum.
Behavioral: Life style change and weight reduction
Patients will be taken care of by general physician without lifestyle program.
Nutritional, behavioural, and exercise counselling to reduce body weight by 10%, normalise blood glucose, lipids, blood pressure, and testosterone level.
Number of participants with normalisation of diabetes or cardiovascular risk or improvement of hypogonadism
Diabetes risk Glycated hemoglobin \>5.7%, Cardiovascular risk score \>5%, Hypogonadism score increase of 20 points
Time frame: 1 year
Plan to share: No
No publications or documents are linked to this record.
Started Jan 2021 (actual). Primary completion is estimated for Dec 2023, 35 months after the start.
Of 594 non-industry interventional studies with no phase under Metabolic Syndrome, half reached primary completion within 20 months of starting (the median), counting those still running; a quarter within 9 and three quarters within 40. This study's planned 35 months is above that.
Counting every sponsor, half of 640 studies reached it within 20 months; a quarter within 9 and three quarters within 40.
How these figures are worked out, and which studies are left out of them.
This study is status unknown, as verified in Nov 2021. You cannot join it, but the record below documents what was studied.
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University of Giessen