Status:
COMPLETED
Effects of 3 Months of Selective Serotonin Reuptake Inhibitor (SSRI)-Treatment on Metabolism and Hypothalamic-pituitary-adrenal (HPA)-Axis in Young Men Born With Low Birth Weight
Lead Sponsor:
University of Aarhus
Conditions:
Insulin Resistance
Low Birth Weight
Eligibility:
MALE
20-35 years
Phase:
NA
Brief Summary
Chronic stress has been proposed to be involved the development of western life-style diseases such as cardiovascular disease and type 2 diabetes (T2DM). At the same time chronic stress is also believ...
Eligibility Criteria
Inclusion
- Healthy men 20-35 years old.
- birth weight \<2500g.
- Born at gestational week 38- 40 (42).
Exclusion
- Diabetes, insulin-resistance or precursors in first degree relatives or maternal gestational diabetes.
- Small parents(mother \<160cm and/or father \<170cm).
- History of abuse of alcohol, medicine og drugs in the mother during pregnancy.
- Liver of renal failure : s-ALAT \> 2.5 normal upper limit (\>175μM) or s-creatinine \>125 μmol/l.
- Co-morbidity that after at medical examination is considered to be a problem.
- BMI\>25.5
- Smoking that is considered to be an issue as regards completing the study.
- Treatment with a MAO-inhibitor.
- Born before gestational week 38.
- Participation in larger X-ray examinations such CT-scans during the last 12 months.
- Participation in medical experiments or treatments involving intravenous administration of radioactive substances during the last
- Ongoing medical treatment that will be considered a issue for completing the study.
- Allergy towards the substance Escitalopram.
- Metal parts in the body that contra-indicates MRI.
- Ongoing medical treatment thrombocyte inhibiting substances such as NSAIDS.
- Previous gastrointestinal bleeding or gastro-duodenal ulcers.
- Depression during examination or treatment
- 16/05-2011: Criterias updated - added 17 and adjusted 6. from BMI \>25 to BMI \>25.5
Key Trial Info
Start Date :
May 1 2009
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
April 1 2014
Estimated Enrollment :
60 Patients enrolled
Trial Details
Trial ID
NCT00971815
Start Date
May 1 2009
End Date
April 1 2014
Last Update
June 5 2017
Active Locations (1)
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1
Medical Dep M, Diabetes and Endocrinology Aarhus University Hospital, Aarhus Sygehus
Aarhus, Denmark, 8000