Growth Hormone Treatment in Men With High Risk of Developing Type 2 Diabetes Mellitus

NCT00781547

Last updated date
Study Location
Centrum for Endocrinology and Metabolism, Sahlgenska University Hospital
Gothenburg, , 413 45, Sweden
Contact
1-800-718-1021

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Eligibility Criteria
condition
The disease, disorder, syndrome, illness, or injury that is being studied.
Abdominal Obesity, Metabolic Syndrome, Obesity
Sex
Male
Age
Pediatric Trials: 0-17 Years
Adult Trials: 18+ Years
40-65 years
Inclusion Criteria
The factors, or reasons, that allow a person to participate in a clinical study.
Show details

- Fasting plasma glucose level ≥ 6.1 and ≤ 7.8 mmol/L (IFG) and/or a plasma glucose 2 hours after a 75g oral glucose load between 6.9-11.0 mmol/L (IGT).

- BMI > 25 kg/m2.

- Waist/hip ratio > 0.95

Exclusion Criteria
The factors, or reasons, that prevent a person from participating in a clinical study.
Show details


- Proliferative diabetic retinopathy.


- Macro-albuminuri and/or serum creatinine >150mmol/L


- Known ischemic heart disease, previous stroke or claudicatio intermittence.


- Known malignancy.


- Other hormonal therapy.

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Abdominal Obesity, Metabolic Syndrome, ObesityGrowth Hormone Treatment in Men With High Risk of Developing Type 2 Diabetes Mellitus
NCT00781547
  1. Gothenburg,
Male
40 Years+
years
MULTIPLE SITES
Advanced Information
Descriptive Information
Brief Title  ICMJE Growth Hormone Treatment in Men With High Risk of Developing Type 2 Diabetes Mellitus
Official Title  ICMJE Not Provided
Brief Summary

The overall aim of this study is to investigate the effects of GH treatment in men with the Metabolic Syndrome and a high risk of developing type 2 DM.

Forty men with abdominal obesity and impaired glucose tolerance will be randomized to two parallel treatment groups with GH and placebo for 12 months.

The subjects will receive treatment with recombinant human GH (Genotropin®) or placebo administered by a daily s.c. injection before bedtime. The initial dose of GH will be 0.4 IU per day increased to 0.8 IU after 2 weeks and to 1.2 IU after 4 weeks of treatment. Thus, the target dose is 1.2 IU per day which resembles approximately 0.015 IU/kg/day. The GH dose will be reduced by half in the event of side-effects. Oral and written instructions in terms of administration and dosage will be given.

The treatment can be discontinued by the patient. The treatment should be discontinued if malignancy is discovered, DM developes, if the subject experience a cerebrovascular disease and in the event of any other side-effects that is considered as serious.

The treatment code for each subject included in the trial will be kept at the Sahlgrenska University Hospital Pharmacy. This code can be broken on the request of the investigator.

Compliance will be assessed by collecting empty vials from the study subjects. The treatment is discontinued at the end of the study.

Detailed Description Not Provided
Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 3
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Condition  ICMJE
  • Abdominal Obesity
  • Metabolic Syndrome
  • Obesity
Intervention  ICMJE Drug: recombinant human growth hormone
The subjects will receive treatment with recombinant human GH (Genotropin®) or placebo administered by a daily s.c. injection before bedtime. The initial dose of GH will be 0.4 IU per day increased to 0.8 IU after 2 weeks and to 1.2 IU after 4 weeks of treatment. Thus, the target dose is 1.2 IU per day which resembles approximately 0.015 IU/kg/day. The GH dose will be reduced by half in the event of side-effects
Study Arms  ICMJE
  • Experimental: Recombinant human growth hormone
    The subjects will receive treatment with recombinant human GH (Genotropin®) or placebo administered by a daily s.c. injection before bedtime. The initial dose of GH will be 0.4 IU per day increased to 0.8 IU after 2 weeks and to 1.2 IU after 4 weeks of treatment. Thus, the target dose is 1.2 IU per day which resembles approximately 0.015 IU/kg/day. The GH dose will be reduced by half in the event of side-effects
    Intervention: Drug: recombinant human growth hormone
  • Placebo Comparator: Placebo
    Intervention: Drug: recombinant human growth hormone
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Completed
Actual Enrollment  ICMJE
 (submitted: October 28, 2008)
40
Original Actual Enrollment  ICMJE Same as current
Actual Study Completion Date  ICMJE May 2005
Actual Primary Completion Date September 2003   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

Inclusion Criteria:

  • Fasting plasma glucose level ? 6.1 and ? 7.8 mmol/L (IFG) and/or a plasma glucose 2 hours after a 75g oral glucose load between 6.9-11.0 mmol/L (IGT).
  • BMI > 25 kg/m2.
  • Waist/hip ratio > 0.95

Exclusion Criteria:

  • Proliferative diabetic retinopathy.
  • Macro-albuminuri and/or serum creatinine >150mmol/L
  • Known ischemic heart disease, previous stroke or claudicatio intermittence.
  • Known malignancy.
  • Other hormonal therapy.
Sex/Gender  ICMJE
Sexes Eligible for Study:Male
Ages  ICMJE 40 Years to 65 Years   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE Sweden
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT00781547
Other Study ID Numbers  ICMJE GHNIDDM
Has Data Monitoring Committee No
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE Not Provided
Responsible Party Gudmundur Johannsson, Department of Endocrinology, Sahlgrenska University Hospital, 413 45 Gothenburg, Sweden
Study Sponsor  ICMJE Göteborg University
Collaborators  ICMJE Pfizer
Investigators  ICMJE Not Provided
PRS Account Göteborg University
Verification Date October 2008

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP