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

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.

Study Overview

• Status: Completed
• Conditions: Obesity; Metabolic Syndrome; Abdominal Obesity
• Intervention / Treatment: Drug: recombinant human growth hormone

• Study Type: Interventional
• Enrollment (Actual): 40
• Phase: Phase 3

Contacts and Locations

Study Locations

• Sweden
  • Gothenburg, Sweden, 413 45
    • Centrum for Endocrinology and Metabolism, Sahlgenska University Hospital

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 40 years to 65 years (ADULT, OLDER_ADULT)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: Male

Description

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: TREATMENT
• Allocation: RANDOMIZED
• Interventional Model: PARALLEL
• Masking: QUADRUPLE

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
PLACEBO_COMPARATOR: Placebo	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
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	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

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
Glucose tolerance	Baseline, 3, 6 and 12 months

Secondary Outcome Measures

Outcome Measure	Time Frame
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

Collaborators and Investigators

• Sponsor: Göteborg University
• Collaborators: Pfizer

Study record dates

Study Major Dates

• Study Start: January 1, 1999
• Primary Completion (ACTUAL): September 1, 2003
• Study Completion (ACTUAL): May 1, 2005

Study Registration Dates

• First Submitted: October 28, 2008
• First Submitted That Met QC Criteria: October 28, 2008
• First Posted (ESTIMATE): October 29, 2008

Study Record Updates

• Last Update Posted (ESTIMATE): October 29, 2008
• Last Update Submitted That Met QC Criteria: October 28, 2008
• Last Verified: October 1, 2008

More Information

Terms related to this study

• Keywords: obesity; growth hormone; abdominal obesity
• Additional Relevant MeSH Terms: Glucose Metabolism Disorders; Metabolic Diseases; Overnutrition; Nutrition Disorders; Overweight; Body Weight; Insulin Resistance; Hyperinsulinism; Obesity; Metabolic Syndrome; Obesity, Abdominal; Physiological Effects of Drugs; Hormones, Hormone Substitutes, and Hormone Antagonists; Hormones
• Other Study ID Numbers: GHNIDDM