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Follow-up of Serum Androgen Profile After Bariatric Surgery in Men With Obesity Related Hypogonadotropic Hypogonadism

This study is currently recruiting participants.
Verified August 2011 by Rijnstate Hospital
Sponsor:
Information provided by:
Rijnstate Hospital
ClinicalTrials.gov Identifier:
NCT00624624
First received: February 15, 2008
Last updated: August 8, 2011
Last verified: August 2011
History of Changes
  Purpose

The purpose of this study is to determine the natural course of the androgen profile after bariatric surgery in men with obesity related hypogonadotropic hypogonadism.


Condition
Morbid Obesity
Hypogonadism

Study Type: Observational
Study Design: Observational Model: Cohort
Time Perspective: Prospective
Official Title: Follow-up of Serum Androgen Profile After Bariatric Surgery in Men With Obesity Related Hypogonadotropic Hypogonadism

Resource links provided by NLM:

U.S. FDA Resources

Further study details as provided by Rijnstate Hospital:

Biospecimen Retention:   Samples Without DNA

serum


Estimated Enrollment: 60
Groups/Cohorts
1
Eugonadal men with "Lapband"
2
Hypogonadal men with "Lapband"
3
Eugonadal men with gastric bypass procedure
4
Hypogonadal men with gastric bypass procedure

  Eligibility

Ages Eligible for Study:   20 Years to 55 Years
Genders Eligible for Study:   Male
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population

Men with planned bariatric surgery

Criteria

Inclusion Criteria:

  • Male
  • Age 20-55 years
  • Planned bariatric procedure
  • Helicobacter pylori negative or adequate HP eradication

Exclusion Criteria:

  • Liver and/or kidney dysfunction
  • Psychiatric disease
  • Medication influencing androgen profile and/or bone metabolism
  • Weight > 160 kg
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00624624

Contacts
Contact: H de Boer, MD, PhD +31-26-3786735 hdeboer@alysis.nl

Locations
Netherlands
Rijnstate Hospital Recruiting
Arnhem, Netherlands, 6800 TA
Principal Investigator: H de Boer, MD, PhD            
Sub-Investigator: B van Wageningen, MD            
Sponsors and Collaborators
Rijnstate Hospital
Investigators
Principal Investigator: H de Boer, MD, PhD Rijnstate Hospital
  More Information

No publications provided

ClinicalTrials.gov Identifier: NCT00624624     History of Changes
Other Study ID Numbers: LTC-472-120607
Study First Received: February 15, 2008
Last Updated: August 8, 2011
Health Authority: Netherlands: Dutch Health Care Inspectorate

Keywords provided by Rijnstate Hospital:
hypogonadotropic hypogonadism
bariatric surgery
serum androgen levels
bone density

Additional relevant MeSH terms:
Hypogonadism
Obesity
Obesity, Morbid
Gonadal Disorders
Endocrine System Diseases
Overnutrition
Nutrition Disorders
Overweight
 Body Weight
Signs and Symptoms
Androgens
Hormones
Hormones, Hormone Substitutes, and Hormone Antagonists
Physiological Effects of Drugs
Pharmacologic Actions

ClinicalTrials.gov processed this record on May 19, 2013