Insulin ResistanceLBW-SSRINCT00971815
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
A study testing Escitalopram in people with Insulin Resistance and Low Birth Weight, run by University of Aarhus at 1 site in Denmark.
Trial 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. Read more about this study
- Who is it for?
- Ages 20 to 35 years, men onlyHealthy volunteers can take part
- Conditions the study is for
- Insulin Resistance, Low Birth Weight, Type 2 Diabetes
- What is being tested?
- Escitalopram
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 60 participants
- Where
- 1 siteDenmark
- Study dates
- May 2009to Apr 2014
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 20 to 35 years
- Men only
- Healthy volunteers accepted
- Adult
Who may be able to join
- Healthy men 20-35 years old.
- birth weight <2500g.
- Born at gestational week 38- 40 (42).
Who cannot join
- 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
Show all 18Show fewer
- 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
Trial locations and contacts
1 site in 1 country.
Denmark1 site
Medical Dep M, Diabetes and Endocrinology Aarhus University Hospital, Aarhus Sygehus
Aarhus, 8000
About this study
Official title: Effects of 3 Months of SSRI-Treatment on Metabolism and HPA-axis in Young Men Born With Low Birth Weight - a Randomized, Double Blinded and Placebo-controlled Trial
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.
Read more
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.
- Conditions
- Insulin Resistance, Low Birth Weight, Type 2 Diabetes, Cardiovascular Disease, Melancholic Depression, Anxiety Disorders
- Being tested
- Escitalopram, placebo
- Keywords
- HPA-axis, fetal programming
- Medical subject headings
- Insulin Resistance, Diabetes Mellitus, Type 2, Cardiovascular Diseases, Depressive Disorder, Anxiety Disorders
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
EscitalopramDrug
Also called Escitalopram (Cipralex)(H. Lundbeck A/S)
first week: 10mg/day. Then, treatment with 20mg/day is continued throughout a 3 months period of time.
placeboDrug
Also called no other names
1/2 pill pr day first week, then 1 pill pr. day throughout a 3 months treatment period (90-118 ± 7days)
| Study group | Role | What they receive |
|---|---|---|
| escitalopram | Active comparator | A pill containing Escitalopram Receives: Drug: Escitalopram |
| placebo | Placebo comparator | a placebo pill Receives: Drug: placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
Changes in rate of glucose dissappearance
Measured: 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
Measured: Changes in LBW-subjects from baseline vs. post-treatment after 3 months treatment with placebo or Escitalopram
Secondary outcomes (19)
24 hour basal plasma cortisol/ACTH profile as measured every 3rd hour.
Measured: 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.
Measured: before and after 3 months of treatment with placebo or Escitalopram
24 hour bloodpressure profile
Measured: before and after 3 months of treatment with placebo or Escitalopram
MRI spectroscopy of fat in skeletal muscle tissue
Measured: Before and after 3 months of treatment with placebo or Escitalopram
MRI spectroscopy of fat in liver
Measured: Before and after 3 months of treatment with placebo or Escitalopram
Abdominal fat as assessed by MRI
Measured: Before and after 3 months of treatment with placebo or Escitalopram
MDI questionnaire scores
Measured: Before and after 3 months of treatment with placebo or Escitalopram
SCL-92 questionnaire scores
Measured: Before and after 3 months of treatment with placebo or Escitalopram
Fasting blood lipid profile
Measured: 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)
Measured: Before and after 3 months of treatment with placebo or Escitalopram
Whole body fat content as assessed by a dexa scanning
Measured: 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)
Measured: 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.
Measured: Before and after 3 months of treatment with placebo or Escitalopram
increase in blood pressure and heart rate during Stroops Stress test
Measured: Before and after 3 months of treatment with placebo or Escitalopram
Increase in plasma ACTH, cortisol and epinephrine concentrations during Stroops Stress Test
Measured: before and after 3 months of treatment with placebo or Escitalopram
SRPAS questionnaire scores
Self Reported Physical Activity Questionaire
Measured: 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
Measured: 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
Measured: Before and after 3 months of treatment with placebo or Escitalopram
Plasma-Inflammation markers
Measured: Before and after 3 months of treatment with placebo or Escitalopram
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted4 Sep 2009 (estimated)
- Study startMay 2009
- Primary completionSep 2011
- Study completionApr 2014
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Insulin ResistanceStudies of the same condition, open and under way.
- More trials run by University of AarhusThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Basic science
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 60 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Aarhus
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00971815
- Sponsor's protocol ID
- M-20080132
- Acronym
- LBW-SSRI
- Status last verified
- May 2013
- First submitted
- 2 Jun 2009
- Last updated
- 5 Jun 2017
- Results posted
- No
- Data monitoring committee
- Yes
Publications
Buhl CS, Stodkilde-Jorgensen H, Videbech P, Vaag A, Moller N, Lund S, Buhl ES. Escitalopram Ameliorates Hypercortisolemia and Insulin Resistance in Low Birth Weight Men With Limbic Brain Alterations. J Clin Endocrinol Metab. 2018 Jan 1;103(1):115-124. doi: 10.1210/jc.2017-01438.
PubMed 29053851
Study at a glance
From the registry record, last updated by the sponsor on 5 Jun 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effects of 3 Months of SSRI-Treatment on Metabolism and HPA-axis in Young Men Born With Low Birth Weight - a Randomized, Double Blinded and Placebo-controlled Trial
- ClinicalTrials.gov ID
- NCT00971815
- Acronym / sponsor ID
- LBW-SSRI / M-20080132
- Conditions
- Insulin Resistance, Low Birth Weight, Type 2 Diabetes, Cardiovascular Disease, Melancholic Depression, Anxiety Disorders
- Keywords
- HPA-axis, fetal programming
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 60 participants (actual)
- Lead sponsor
- University of AarhusUniversity, hospital or other
- Study start
- May 2009
- Primary completion
- Sep 2011 (actual)
- Study completion
- Apr 2014 (actual)
- First posted
- 4 Sep 2009 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Basic science
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| escitalopram | Active comparator | Drug: EscitalopramA pill containing Escitalopram |
| placebo | Placebo comparator | Drug: placeboa placebo pill |
Who may qualify
- Ages
- 20 to 35 years
- Sex
- Male only
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (3 listed)
- Healthy men 20-35 years old.
- birth weight <2500g.
- Born at gestational week 38- 40 (42).
Key exclusion criteria (18 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| EscitalopramAlso: Escitalopram (Cipralex)(H. Lundbeck A/S)first week: 10mg/day. Then, treatment with 20mg/day is continued throughout a 3 months period of time. | Drug | escitalopram |
| placeboAlso: no other names1/2 pill pr day first week, then 1 pill pr. day throughout a 3 months treatment period (90-118 ± 7days) | Drug | placebo |
Primary outcome
Changes in rate of glucose dissappearance
Time frame: 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
Time frame: Changes in LBW-subjects from baseline vs. post-treatment after 3 months treatment with placebo or Escitalopram
19 secondary outcomes
24 hour basal plasma cortisol/ACTH profile as measured every 3rd hour.
Time frame: before and after 3 months of treatment with placebo or Escitalopram
hippocampic volume and structure as assessed by MRI
Time frame: before and after 3 months of treatment with placebo or Escitalopram
24 hour bloodpressure profile
Time frame: before and after 3 months of treatment with placebo or Escitalopram
MRI spectroscopy of fat in skeletal muscle tissue
Time frame: Before and after 3 months of treatment with placebo or Escitalopram
MRI spectroscopy of fat in liver
Time frame: Before and after 3 months of treatment with placebo or Escitalopram
Abdominal fat as assessed by MRI
Time frame: Before and after 3 months of treatment with placebo or Escitalopram
MDI questionnaire scores
Time frame: Before and after 3 months of treatment with placebo or Escitalopram
SCL-92 questionnaire scores
Time frame: Before and after 3 months of treatment with placebo or Escitalopram
Fasting blood lipid profile
Time frame: 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)
Time frame: Before and after 3 months of treatment with placebo or Escitalopram
Whole body fat content as assessed by a dexa scanning
Time frame: 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)
Time frame: 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.
Time frame: Before and after 3 months of treatment with placebo or Escitalopram
increase in blood pressure and heart rate during Stroops Stress test
Time frame: Before and after 3 months of treatment with placebo or Escitalopram
Increase in plasma ACTH, cortisol and epinephrine concentrations during Stroops Stress Test
Time frame: before and after 3 months of treatment with placebo or Escitalopram
SRPAS questionnaire scores
Time frame: Before and after 3 months of treatment with placebo or Escitalopram
Actigraph GT3X activity monitoring
Time frame: 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
Time frame: Before and after 3 months of treatment with placebo or Escitalopram
Plasma-Inflammation markers
Time frame: Before and after 3 months of treatment with placebo or Escitalopram
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 5 Jun 2017.
- Derived from this study: PubMed 29053851Buhl CS, Stodkilde-Jorgensen H, Videbech P, Vaag A, Moller N, Lund S, Buhl ES. Escitalopram Ameliorates Hypercortisolemia and Insulin Resistance in Low Birth Weight Men With Limbic Brain Alterations. J Clin Endocrinol Metab. 2018 Jan 1;103(1):115-124. doi: 10.1210/jc.2017-01438.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Escitalopram in people with Insulin Resistance and Low Birth Weight, run by University of Aarhus at 1 site in Denmark.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 18 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 5 Jun 2017. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Denmark. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Changes in rate of glucose dissappearance (time frame: Changes in LBW-subjects from baseline vs. post-treatment after 3 months treatment with placebo or Escitalopram). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT00971815, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 5 Jun 2017.