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
Condition: Insulin Resistance; Low Birth Weight; Type 2 Diabetes; Cardiovascular Disease; Melancholic Depression; Anxiety Disorders
MeSH terms: Cardiovascular Diseases; Insulin Resistance; Body Weight; Birth Weight; Anxiety Disorders
Study type: Interventional

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 believed to cause psychiatric disease such as melancholic depression (MD)and
      anxiety disorders.

      Accordingly, humans born with low birth weight (LBW) (ei. less than 5,0 LB) display an
      increased risk for T2DM and MD. Studies suggest stress and adrenal stress hormones
      (glucocorticoids) (GCC) might be involved in the development of both of these conditions.

      Recent studies of animals born LBW suggest, that SSRI-compounds, usually employed in the
      treatment of MD-related diseases, reduces stress-responses and levels of stress hormones such
      adrenal steroids and at the same time has a positive influence on glucose metabolism.

      In present study, the investigators aim to measure levels of GCC and stress and assess
      glucose metabolism in healthy young men (20-35 years) born LBW (40 subjects). The volume and
      structure of a certain brain area (ie. hippocampus) involved in regulation of adrenal GCC and
      known to be malfunctioning in chronically stressed individuals will be assessed by magnetic
      resonance imaging (MRI). Further metabolic examination will be accompanied by MRI
      spectroscopy of liver and muscle fat content as well as total fat content (Dexa-scanning) and
      contents of fat in the abdomen (by MRI) . Psychiatric well-ness and symptoms will be
      characterized by well-established questionnaires such as MDI and SCL-92 and responses as
      regards blood pressure, heart rate and changes in basal plasma concentrations of GCC and
      Epinephrine will be assessed while performing a Stroop Stress Test. Finally, a 24 hour blood
      pressure profile test will be included.

      After this extensive examination program, subjects will be randomized to 3-4 months of
      treatment with either Escitalopram (an SSRI-compound) or Placebo. Subsequently, at the end of
      the treatment, the whole examination program will be repeated to detect potential beneficial
      changes.

      A group of young normal birth weight men (20 subjects) will serve as a healthy baseline group
      for comparison and will not be exposed to any medical treatment.

      This trial will add understanding to the mechanism underlying the development of type 2
      diabetes and depression in LBW. Additionally, present trial might be capable of proposing a
      novel treatment strategy to prevent the development of these diseases in LBW man.
    


Intervention name(s): Escitalopram; placebo
Intervention type(s): Drug; Drug
Intervention description(s): first week: 10mg/day. Then, treatment with 20mg/day is continued throughout a 3 months period of time.; 1/2 pill pr day first week, then 1 pill pr. day throughout a 3 months treatment period (90-118 ± 7days)
Other intervention name(s): Escitalopram (Cipralex)(H. Lundbeck A/S); no other names
Intervention MeSH terms: Dexetimide; Citalopram; Escitalopram
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary purpose: Basic Science
Keywords: HPA-axis; fetal programming