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Clinical Trial Details

Trial ID: L6167
Source ID: NCT00971815
Associated Drug: Escitalopram
Title: 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
Acronym: LBW-SSRI
Status: COMPLETED
Study Results: NO
Results:
Conditions: Insulin Resistance|Low Birth Weight|Type 2 Diabetes|Cardiovascular Disease|Melancholic Depression|Anxiety Disorders
Interventions: DRUG: Escitalopram|DRUG: placebo
Outcome Measures: Primary: Changes in rate of glucose dissappearance, Changes in LBW-subjects from baseline vs. post-treatment after 3 months treatment with placebo or Escitalopram|Changes in the 24-hour AUC of free plasma cortisol, Changes in LBW-subjects from baseline vs. post-treatment after 3 months treatment with placebo or Escitalopram | Secondary: 24 hour basal plasma cortisol/ACTH profile as measured every 3rd hour., before and after 3 months of treatment with placebo or Escitalopram|hippocampic volume and structure as assessed by MRI, All limbic structures (amygdala, thalamus, hippocampus and ventromedial prefrontal cortex) were morphologically and volumetrically analyzed., before and after 3 months of treatment with placebo or Escitalopram|24 hour bloodpressure profile, before and after 3 months of treatment with placebo or Escitalopram|MRI spectroscopy of fat in skeletal muscle tissue, Before and after 3 months of treatment with placebo or Escitalopram|MRI spectroscopy of fat in liver, Before and after 3 months of treatment with placebo or Escitalopram|Abdominal fat as assessed by MRI, Before and after 3 months of treatment with placebo or Escitalopram|MDI questionnaire scores, Before and after 3 months of treatment with placebo or Escitalopram|SCL-92 questionnaire scores, Before and after 3 months of treatment with placebo or Escitalopram|Fasting blood lipid profile, Before and after 3 months of treatment with placebo or Escitalopram|Ratio between insulin and glucose concentrations in blood during an oral glucose tolerance test (OGTT), Before and after 3 months of treatment with placebo or Escitalopram|Whole body fat content as assessed by a dexa scanning, Before and after 3 months of treatment with placebo or Escitalopram|Hepatic insulin sensitivity as assessed suppression of endogenous glucose production (calculated by infusion of 3H-labelled glucose), Before and after 3 months of treatment with placebo or Escitalopram|10 pm to midnight basal plasma ACTH/cortisol concentration ratio as measured by blood sampling every 10th minute., Before and after 3 months of treatment with placebo or Escitalopram|increase in blood pressure and heart rate during Stroops Stress test, Before and after 3 months of treatment with placebo or Escitalopram|Increase in plasma ACTH, cortisol and epinephrine concentrations during Stroops Stress Test, before and after 3 months of treatment with placebo or Escitalopram|SRPAS questionnaire scores, Self Reported Physical Activity Questionaire, Before and after 3 months of treatment with placebo or Escitalopram|Actigraph GT3X activity monitoring, Objective measurements of physical activity in 96 hours at home, Before and after 3 months of treatment with placebo or Escitalopram|Whole body bone mass density and T-/Z-scores as assessed by a dexa scanning, Before and after 3 months of treatment with placebo or Escitalopram|Plasma-Inflammation markers, Before and after 3 months of treatment with placebo or Escitalopram
Sponsor/Collaborators: Sponsor: University of Aarhus
Gender: MALE
Age: ADULT
Phases:
Enrollment: 60
Study Type: INTERVENTIONAL
Study Designs: Allocation: RANDOMIZED|Intervention Model: PARALLEL|Masking: QUADRUPLE (PARTICIPANT, CARE_PROVIDER, INVESTIGATOR, OUTCOMES_ASSESSOR)|Primary Purpose: BASIC_SCIENCE
Start Date: 2009-05
Completion Date: 2014-04
Results First Posted:
Last Update Posted: 2017-06-05
Locations: Medical Dep M, Diabetes and Endocrinology Aarhus University Hospital, Aarhus Sygehus, Aarhus, 8000, Denmark
URL: https://clinicaltrials.gov/show/NCT00971815