ObesityPhase 2NCT00151684
Diazoxide-Mediated Insulin Suppression in Hyperinsulinemic Obese Men
A Phase 2 study testing Diazoxide in people with Obesity and Hyperinsulinism, run by Rijnstate Hospital at 1 site in Netherlands.
Trial summary
The purpose of this study is to explore diazoxide efficacy in treatment of obese men and assessment of maximal insulin suppression in obese men without hyperglycaemia. Obesity is associated with markedly elevated plasma insulin levels throughout the day. Read more about this study
- Who is it for?
- Ages 30 to 50 years, men onlyHealthy volunteers can take part
- Conditions the study is for
- Obesity, Hyperinsulinism
- What is being tested?
- Diazoxide
- How many people
- 25 participants
- Where
- 1 siteNetherlands
- Study dates
- Nov 2004to not given
- Phase
- Phase 2
- 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 30 to 50 years
- Men only
- Healthy volunteers accepted
- Adult
Who may be able to join
- fasting glucose < 7.0 mmol/L
- fasting C-peptide plasma level > 1.0 nmol/L
- HbA1c of 6.0% or lower
- Absence of comorbidity
- Absence of medication use
Who cannot join
- Plasma Creatinine > 120 micromol/L
- Liverenzymes > 2 times the upper normal limit
- Gout
- Alcohol use > 2 units/day
- Illicit drug use
- Quit smoking less than 6 months ago
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Diazoxide-Mediated Insulin Suppression in Hyperinsulinemic Obese Men: a Dose Response Study, Part II
The purpose of this study is to explore diazoxide efficacy in treatment of obese men and assessment of maximal insulin suppression in obese men without hyperglycaemia.
Obesity is associated with markedly elevated plasma insulin levels throughout the day. The concept is that obese subjects predominantly develop lean tissue resistance against the glucoregulatory actions of insulin, but remain relatively sensitive to the lipogenic and antilipolytic effects of insulin in adipose tissue. According to this theory, suppression of hyperinsulinism by diazoxide, a well known inhibitor of glucose stimulated insulin secretion, might be useful to treat obesity because it will help to reverse the process of lipid storage.
Read the detailed description
The purpose of this study is to explore diazoxide efficacy in treatment of obese men and assessment of maximal insulin suppression in obese men without hyperglycaemia.
Study design:
This study is an open-labelled, non-randomized, phase IIa study.
Treatment:
During a 6 month period, the dosage of Diazoxide will be raised gradually until a maximum of 900 mg/day, under control of bloodpressure and glucose levels.
Endpoints, monthly determined:
- body weight
- abdominal circumference
- body composition measured by Dual Energy X-ray Absorptiometry
- glucose tolerance
- Conditions
- Obesity, Hyperinsulinism
- Being tested
- Diazoxide
- Keywords
- Obesity, Hyperinsulinism, Diazoxide
- Medical subject headings
- Obesity, Hyperinsulinism
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
DiazoxideDrug
What is being measured
The primary outcome is the main question the study is designed to answer.
body weight
abdominal circumference
body composition measured by Dual Energy X-ray Absorptiometry
glucose tolerance
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted9 Sep 2005 (estimated)
- Study startNov 2004
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for ObesityStudies of the same condition, open and under way.
- 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 2
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 25 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Rijnstate Hospital
- Sponsor type
- University, hospital or other
- Investigators
- Hans de Boer, MD PhD, Principal investigator, Rijnstate Hospital, Arnhem, The Netherlands
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00151684
- Sponsor's protocol ID
- LTC-268-060504
- Status last verified
- Feb 2008
- First submitted
- 8 Sep 2005
- Last updated
- 29 Feb 2008
- Results posted
- No
Publications
Schreuder T, Karreman M, Rennings A, Ruinemans-Koerts J, Jansen M, de Boer H. Diazoxide-mediated insulin suppression in obese men: a dose-response study. Diabetes Obes Metab. 2005 May;7(3):239-45. doi: 10.1111/j.1463-1326.2004.00449.x.
PubMed 15811140
Study at a glance
From the registry record, last updated by the sponsor on 29 Feb 2008. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Diazoxide-Mediated Insulin Suppression in Hyperinsulinemic Obese Men: a Dose Response Study, Part II
- ClinicalTrials.gov ID
- NCT00151684
- Acronym / sponsor ID
- LTC-268-060504
- Conditions
- Obesity, Hyperinsulinism
- Keywords
- Obesity, Hyperinsulinism, Diazoxide
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 25 participants (estimated)
- Lead sponsor
- Rijnstate HospitalUniversity, hospital or other
- Study start
- Nov 2004
- First posted
- 9 Sep 2005 (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 purpose of this study is to explore diazoxide efficacy in treatment of obese men and assessment of maximal insulin suppression in obese men without hyperglycaemia.
Obesity is associated with markedly elevated plasma insulin levels throughout the day. The concept is that obese subjects predominantly develop lean tissue resistance against the glucoregulatory actions of insulin, but remain relatively sensitive to the lipogenic and antilipolytic effects of insulin in adipose tissue. According to this theory, suppression of hyperinsulinism by diazoxide, a well known inhibitor of glucose stimulated insulin secretion, might be useful to treat obesity because it will help to reverse the process of lipid storage.
Detailed description
The purpose of this study is to explore diazoxide efficacy in treatment of obese men and assessment of maximal insulin suppression in obese men without hyperglycaemia.
Study design:
This study is an open-labelled, non-randomized, phase IIa study.
Treatment:
During a 6 month period, the dosage of Diazoxide will be raised gradually until a maximum of 900 mg/day, under control of bloodpressure and glucose levels.
Endpoints, monthly determined:
- body weight
- abdominal circumference
- body composition measured by Dual Energy X-ray Absorptiometry
- glucose tolerance
Study design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Single group
- Masking
- None (open label)
Who may qualify
- Ages
- 30 to 50 years
- Sex
- Male only
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (5 listed)
- fasting glucose < 7.0 mmol/L
- fasting C-peptide plasma level > 1.0 nmol/L
- HbA1c of 6.0% or lower
- Absence of comorbidity
- Absence of medication use
Key exclusion criteria (6 listed)
- Plasma Creatinine > 120 micromol/L
- Liverenzymes > 2 times the upper normal limit
- Gout
- Alcohol use > 2 units/day
- Illicit drug use
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 |
|---|---|---|
| Diazoxide | Drug | – |
Primary outcome
body weight
abdominal circumference
body composition measured by Dual Energy X-ray Absorptiometry
glucose tolerance
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 Feb 2008.
- Background: PubMed 15811140Schreuder T, Karreman M, Rennings A, Ruinemans-Koerts J, Jansen M, de Boer H. Diazoxide-mediated insulin suppression in obese men: a dose-response study. Diabetes Obes Metab. 2005 May;7(3):239-45. doi: 10.1111/j.1463-1326.2004.00449.x.
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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.
Hans de Boer, MD PhD principal investigator
Rijnstate Hospital, Arnhem, The Netherlands
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing Diazoxide in people with Obesity and Hyperinsulinism, run by Rijnstate Hospital at 1 site in Netherlands.
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 5 inclusion and 6 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 Feb 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 Netherlands. 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. 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 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
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?
body weight. The study lists 4 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT00151684, which also lists 1 linked publication.
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 Feb 2008.