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

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

60 participants

Study Classification

INTERVENTIONAL

Study Start Date

2009-05-31

Study Completion Date

2014-04-30

Brief Summary

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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.

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Detailed Description

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Conditions

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Insulin Resistance Low Birth Weight Type 2 Diabetes Cardiovascular Disease Melancholic Depression Anxiety Disorders

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

BASIC_SCIENCE

Blinding Strategy

QUADRUPLE

Participants Caregivers Investigators Outcome Assessors

Study Groups

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escitalopram

A pill containing Escitalopram

Group Type ACTIVE_COMPARATOR

Escitalopram

Intervention Type DRUG

first week: 10mg/day. Then, treatment with 20mg/day is continued throughout a 3 months period of time.

placebo

a placebo pill

Group Type PLACEBO_COMPARATOR

placebo

Intervention Type DRUG

1/2 pill pr day first week, then 1 pill pr. day throughout a 3 months treatment period (90-118 ± 7days)

Interventions

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Escitalopram

first week: 10mg/day. Then, treatment with 20mg/day is continued throughout a 3 months period of time.

Intervention Type DRUG

placebo

1/2 pill pr day first week, then 1 pill pr. day throughout a 3 months treatment period (90-118 ± 7days)

Intervention Type DRUG

Other Intervention Names

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Escitalopram (Cipralex)(H. Lundbeck A/S) no other names

Eligibility Criteria

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Inclusion Criteria

1. Healthy men 20-35 years old.
2. birth weight \<2500g.
3. Born at gestational week 38- 40 (42).

Exclusion Criteria

1. Diabetes, insulin-resistance or precursors in first degree relatives or maternal gestational diabetes.
2. Small parents(mother \<160cm and/or father \<170cm).
3. History of abuse of alcohol, medicine og drugs in the mother during pregnancy.
4. Liver of renal failure : s-ALAT \> 2.5 normal upper limit (\>175μM) or s-creatinine \>125 μmol/l.
5. Co-morbidity that after at medical examination is considered to be a problem.
6. BMI\>25.5
7. Smoking that is considered to be an issue as regards completing the study.
8. Treatment with a MAO-inhibitor.
9. Born before gestational week 38.
10. Participation in larger X-ray examinations such CT-scans during the last 12 months.
11. Participation in medical experiments or treatments involving intravenous administration of radioactive substances during the last
12. Ongoing medical treatment that will be considered a issue for completing the study.
13. Allergy towards the substance Escitalopram.
14. Metal parts in the body that contra-indicates MRI.
15. Ongoing medical treatment thrombocyte inhibiting substances such as NSAIDS.
16. Previous gastrointestinal bleeding or gastro-duodenal ulcers.
17. Depression during examination or treatment

16/05-2011: Criterias updated - added 17 and adjusted 6. from BMI \>25 to BMI \>25.5

Minimum Eligible Age

20 Years

Maximum Eligible Age

35 Years

Eligible Sex

MALE

Accepts Healthy Volunteers

Yes