Abdominal ObesityPhase 3GHDMNCT00781547
Growth Hormone Treatment in Men With High Risk of Developing Type 2 Diabetes Mellitus
A Phase 3 study testing recombinant human growth hormone in people with Abdominal Obesity and Metabolic Syndrome, run by Göteborg University at 1 site in Sweden.
Trial 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. Read more about this study
- Who is it for?
- Ages 40 to 65 years, men only
- Conditions the study is for
- Abdominal Obesity, Metabolic Syndrome, Obesity
- What is being tested?
- recombinant human growth hormone
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 40 participants
- Where
- 1 siteSweden
- Study dates
- Jan 1999to May 2005
- Phase
- Phase 3
- 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 40 to 65 years
- Men only
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country.
Sweden1 site
Centrum for Endocrinology and Metabolism, Sahlgenska University Hospital
Gothenburg, 413 45
About this study
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.
Read more
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
- Being tested
- recombinant human growth hormone
- Keywords
- growth hormone, obesity, abdominal obesity
- Medical subject headings
- Obesity, Abdominal, Metabolic Syndrome, Obesity
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
recombinant human growth hormoneDrug
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 group | Role | What they receive |
|---|---|---|
| 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 Receives: Drug: recombinant human growth hormone |
| Placebo | Placebo comparator | Not described Receives: Drug: recombinant human growth hormone |
What is being measured
The primary outcome is the main question the study is designed to answer.
Glucose tolerance
Measured: Baseline, 3, 6 and 12 months
Secondary outcomes (4)
Fasting plasma glucose, serum insulin, HbA1c
Measured: Basline, 1,2,3,6,9 and 12 months
Sleep architecture
Measured: Baseline and 12 months
Visceral adipose tissue
Measured: Baseline and 12 months
Progress of atherosclerosis (IMT)
Measured: Baseline and 12 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted29 Oct 2008 (estimated)
- Study startJan 1999
- Primary completionSep 2003
- Study completionMay 2005
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Abdominal ObesityStudies of the same condition, open and under way.
- More trials run by Göteborg UniversityThe 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 3
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 40 participants (actual)
Sponsor and investigators
- Lead sponsor
- Göteborg University
- Sponsor type
- University, hospital or other
- Collaborators
- Pfizer
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00781547
- Sponsor's protocol ID
- GHNIDDM
- Acronym
- GHDM
- Status last verified
- Oct 2008
- First submitted
- 28 Oct 2008
- Last updated
- 29 Oct 2008
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 29 Oct 2008. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Growth Hormone Treatment in Men With High Risk of Developing Type 2 Diabetes Mellitus
- ClinicalTrials.gov ID
- NCT00781547
- Acronym / sponsor ID
- GHDM / GHNIDDM
- Conditions
- Abdominal Obesity, Metabolic Syndrome, Obesity
- Keywords
- growth hormone, obesity, abdominal obesity
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 40 participants (actual)
- Lead sponsor
- Göteborg UniversityUniversity, hospital or other
- Collaborators
- Pfizer
- Study start
- Jan 1999
- Primary completion
- Sep 2003 (actual)
- Study completion
- May 2005 (actual)
- First posted
- 29 Oct 2008 (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.
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 design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Recombinant human growth hormone | Experimental | Drug: recombinant human growth hormoneThe 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 | Placebo comparator | Drug: recombinant human growth hormone |
Who may qualify
- Ages
- 40 to 65 years
- Sex
- Male only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- 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
Key exclusion criteria (5 listed)
- 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.
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 |
|---|---|---|
| recombinant human growth hormoneThe 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 | Placebo, Recombinant human growth hormone |
Primary outcome
Glucose tolerance
Time frame: Baseline, 3, 6 and 12 months
4 secondary outcomes
Fasting plasma glucose, serum insulin, HbA1c
Time frame: Basline, 1,2,3,6,9 and 12 months
Sleep architecture
Time frame: Baseline and 12 months
Visceral adipose tissue
Time frame: Baseline and 12 months
Progress of atherosclerosis (IMT)
Time frame: Baseline and 12 months
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 29 Oct 2008.
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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 Phase 3 study testing recombinant human growth hormone in people with Abdominal Obesity and Metabolic Syndrome, run by Göteborg University at 1 site in Sweden.
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 5 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 29 Oct 2008. 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 Sweden. 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.
What does this phase mean?
Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
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?
Glucose tolerance (time frame: Baseline, 3, 6 and 12 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 29 Oct 2008.