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

NCT00781547 | Completed Phase 3

• 1 other identifier: GHNIDDM
• Study Type: interventional
• Target: 40
• Locations: 1 country
• Sites: 1

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.

Conditions

Abdominal Obesity; Metabolic Syndrome; Obesity

Keywords

growth hormone; obesity; abdominal obesity

Outcome Measures

Primary Outcomes (1)

• Glucose tolerance

  Baseline, 3, 6 and 12 months

Secondary Outcomes (4)

• Fasting plasma glucose, serum insulin, HbA1c

  Basline, 1,2,3,6,9 and 12 months

• Sleep architecture

  Baseline and 12 months

• Visceral adipose tissue

  Baseline and 12 months

• Progress of atherosclerosis (IMT)

  Baseline and 12 months

Study Arms (2)

Recombinant human growth hormone

EXPERIMENTAL

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

Drug: recombinant human growth hormone

Placebo

PLACEBO COMPARATOR

Drug: recombinant human growth hormone

Interventions

recombinant human growth hormone DRUG

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

Placebo; Recombinant human growth hormone

Eligibility Criteria

• Age: 40 Years - 65 Years
• Sex: male
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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.

Sponsors & Collaborators

• Göteborg University: lead
• Pfizer: collaborator

Study Sites (1)

Centrum for Endocrinology and Metabolism, Sahlgenska University Hospital

Gothenburg, 413 45, Sweden

Location

MeSH Terms

Conditions

Obesity, Abdominal; Metabolic Syndrome; Obesity

Interventions

Growth Hormone

Condition Hierarchy (Ancestors)

Overweight; Overnutrition; Nutrition Disorders; Nutritional and Metabolic Diseases; Body Weight; Signs and Symptoms; Pathological Conditions, Signs and Symptoms; Insulin Resistance; Hyperinsulinism; Glucose Metabolism Disorders; Metabolic Diseases

Intervention Hierarchy (Ancestors)

Pituitary Hormones, Anterior; Pituitary Hormones; Peptide Hormones; Hormones; Hormones, Hormone Substitutes, and Hormone Antagonists; Peptides; Amino Acids, Peptides, and Proteins

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER

Study Record Dates

• First Submitted: October 28, 2008
• First Posted: October 29, 2008
• Study Start: January 1, 1999
• Primary Completion: September 1, 2003
• Study Completion: May 1, 2005
• Last Updated: October 29, 2008

Record last verified: 2008-10

Locations

SE (1)