ObesityNCT00413335
Effects of Rosiglitazone on the Metabolic Phenotype of Impaired Glucose Tolerance in Youth
A study testing Rosiglitazone in people with Obesity and Impaired Glucose Tolerance, run by Yale University at 1 site in United States.
Trial summary
The purpose of the study is to determine whether treatment of children and adolescents with Impaired Glucose Tolerance (IGT) with rosiglitazone will lead to improvements in insulin sensitivity and glucose tolerance. Read more about this study
- Who is it for?
- Ages 10 to 18 years
- Conditions the study is for
- Obesity, Impaired Glucose Tolerance, Type 2 Diabetes Mellitus
- What is being tested?
- Rosiglitazone
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 21 participants
- Where
- 1 siteUnited States
- Study dates
- Nov 2005to Dec 2008
- Phase
- Interventional
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
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 10 to 18 years
- All sexes
- No healthy volunteers
- Child, Adult
Who may be able to join
- Good general health
- Aged 10 to 18 yrs (females: Tanner stage II-V;and males:testes size>6ml)
- IGT based on 2-hr plasma glucose>140mg/dl and <200mg/dl during an OGTT.
Who cannot join
- Baseline creatinine>1.0mg
- AST and ALT>2.5 ULN
- Anemia (Hct<30)
- Pregnancy (females must have a negative urine pregnancy test during the study)
- Cardiac or pulmonary or other significant chronic illness
- Plans to increase the frequency or intensity of a regular exercise program
- Psychiatric disorder or substance abuse of anorexic agents.
Trial locations and contacts
1 site in 1 country.
United States1 site
Yale School of Medicine
New Haven, Connecticut, 06520
About this study
The purpose of the study is to determine whether treatment of children and adolescents with Impaired Glucose Tolerance (IGT) with rosiglitazone will lead to improvements in insulin sensitivity and glucose tolerance.
Read the detailed description
Impaired Glucose Tolerance (IGT) is a prelude to diabetes, which is increasing in prevalence in obese children and adolescents with marked obesity. This condition tends to progress to Type 2 Diabetes Mellitus (T2DM) at an alarmingly rapid tempo. The increased prevalence of childhood and adolescent obesity and greater risk of IGT, and progression to diabetes, in this population set the stage for a series of studies aimed at understanding the metabolic phenotype and natural history of pre-diabetes in obese youth. The investigators found that obese children and adolescents with IGT are characterized by marked insulin resistance related to altered lipid partitioning, favoring lipid deposition in the visceral and intramyocellular compartment. Furthermore, the investigators found an impairment of the acute insulin response in these youngsters. Follow-up revealed a rapid deterioration from IGT to frank diabetes. Based on these studies, there is a strong rationale for changing the balance between visceral and subcutaneous fat and muscle lipid content in a more favorable pattern in order to improve insulin sensitivity.
The primary objective of this study is to determine, in a group of ethnically diverse children and adolescents with IGT, whether treatment with rosiglitazone leads to improvements in insulin sensitivity and glucose tolerance. Secondary objectives are to determine whether rosiglitazone is safe and well tolerated.
- Being tested
- Rosiglitazone, Placebo
- Keywords
- Childhood and Adolescent Obesity, Metabolic phenotype, Impaired Glucose Tolerance, Type 2 Diabetes Mellitus, Insulin Sensitivity, Insulin Resistance, Abdominal fat partitioning, Impaired Glucose Tolerance (IGT), Type 2 Diabetes Mellitus (T2DM)
- Medical subject headings
- Obesity, Glucose Intolerance, Diabetes Mellitus, Type 2, Pediatric Obesity, Insulin Resistance
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
RosiglitazoneDrug
Also called Avandia
2mg to begin then 4mg, twice daily for 4 months
PlaceboDrug
Subject receives placebo.
| Study group | Role | What they receive |
|---|---|---|
| 1 | Active comparator | Subject undergoes ogtt, hyperinsulinemic-euglycemic clamp, abdominal and liver MRI, NMR and DEXA scan. Subject then receives Rosiglitazone. Subjects are followed every 2 weeks. Imaging repeated at 2 months. 12 week follow up. And then all tests are repeated at 4 months. Receives: Drug: Rosiglitazone |
| 2 | Placebo comparator | Subject has ogtt, hyperinsulinemic-euglycemic clamp, abdominal and liver MRI, DEXA, NMR. Subject is randomized (double-blind) to placebo. Is followed every 2 weeks, repeats imaging at 2 months, is seen at 12 weeks and then repeats all tests at 2 months. Receives: Drug: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
Mean Percent Change From Baseline in Whole-body Insulin Sensitivity
This describes the percent changes in insulin sensitivity. Insulin sensitivity was expressed as whole body insulin sensitivity index (WBISI) which is based on the values of insulin (microunits per milliliter) and glucose (milligrams per deciliter) obtained from the OGTT and the corresponding fasting values.The formula is: WBISI=10.000/square root of (fasting glucose x fasting insulin)x(mean glucose x mean insulin).
Measured: 4 months
Mean Percent Change in Visceral-to-subcutaneous Abdominal Fat
This describes the percent changes of the ratio between visceral and subcutaneous abdominal fat.
Measured: 4 months
Percentage of Subjects Who Converted Impaired Glucose Tolerance (IGT) to Normal Glucose Tolerance (NGT)
This refers to the number of subjects that converted from IGT to NGT. NGT is defined as fasting glucose lower than 100 mg/dl and 2 hours glucose lower than 140 mg/dl. IGT is defined as 2 hours glucose higher than 140 mg/dl.
Measured: 4 months
Mean Percent Change From Baseline in Hepatic Fat Fraction (HFF)
It refers to the percent changes of hepatic fat content.
Measured: 4 months
Secondary outcomes (1)
Mean Percent Change From Baseline in Adiponectin
This refers to the changes of adiponectin levels.
Measured: 4 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted19 Dec 2006 (estimated)
- Study startNov 2005
- Primary completionSep 2008
- Study completionDec 2008
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Other trials for ObesityStudies of the same condition, open and under way.
- More trials run by Yale 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 N/A
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 21 participants (actual)
Sponsor and investigators
- Lead sponsor
- Yale University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Sonia Caprio, Yale University
- Investigators
- Sonia Caprio, MD, Principal investigator, Yale School of Medicine Department of Pediatric Endocrinology
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00413335
- Sponsor's protocol ID
- 0508000532
- Status last verified
- Jul 2013
- First submitted
- 15 Dec 2006
- Last updated
- 22 Jul 2013
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 22 Jul 2013. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effects of Rosiglitazone on the Metabolic Phenotype of Impaired Glucose Tolerance in Youth
- ClinicalTrials.gov ID
- NCT00413335
- Acronym / sponsor ID
- 0508000532
- Keywords
- Childhood and Adolescent Obesity, Metabolic phenotype, Impaired Glucose Tolerance, Type 2 Diabetes Mellitus, Insulin Sensitivity, Insulin Resistance, Abdominal fat partitioning, Impaired Glucose Tolerance (IGT)
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 21 participants (actual)
- Lead sponsor
- Yale UniversityUniversity, hospital or other
- Study start
- Nov 2005
- Primary completion
- Sep 2008 (actual)
- Study completion
- Dec 2008 (actual)
- First posted
- 19 Dec 2006 (estimated)
- Results
- Posted 19 Apr 2013
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 the study is to determine whether treatment of children and adolescents with Impaired Glucose Tolerance (IGT) with rosiglitazone will lead to improvements in insulin sensitivity and glucose tolerance.
Detailed description
Impaired Glucose Tolerance (IGT) is a prelude to diabetes, which is increasing in prevalence in obese children and adolescents with marked obesity. This condition tends to progress to Type 2 Diabetes Mellitus (T2DM) at an alarmingly rapid tempo. The increased prevalence of childhood and adolescent obesity and greater risk of IGT, and progression to diabetes, in this population set the stage for a series of studies aimed at understanding the metabolic phenotype and natural history of pre-diabetes in obese youth. The investigators found that obese children and adolescents with IGT are characterized by marked insulin resistance related to altered lipid partitioning, favoring lipid deposition in the visceral and intramyocellular compartment. Furthermore, the investigators found an impairment of the acute insulin response in these youngsters. Follow-up revealed a rapid deterioration from IGT to frank diabetes. Based on these studies, there is a strong rationale for changing the balance between visceral and subcutaneous fat and muscle lipid content in a more favorable pattern in order to improve insulin sensitivity.
The primary objective of this study is to determine, in a group of ethnically diverse children and adolescents with IGT, whether treatment with rosiglitazone leads to improvements in insulin sensitivity and glucose tolerance. Secondary objectives are to determine whether rosiglitazone is safe and well tolerated.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| 1 | Active comparator | Drug: RosiglitazoneSubject undergoes ogtt, hyperinsulinemic-euglycemic clamp, abdominal and liver MRI, NMR and DEXA scan. Subject then receives Rosiglitazone. Subjects are followed every 2 weeks. Imaging repeated at 2 months. 12 week follow up. And then all tests are repeated at 4 months. |
| 2 | Placebo comparator | Drug: PlaceboSubject has ogtt, hyperinsulinemic-euglycemic clamp, abdominal and liver MRI, DEXA, NMR. Subject is randomized (double-blind) to placebo. Is followed every 2 weeks, repeats imaging at 2 months, is seen at 12 weeks and then repeats all tests at 2 months. |
Who may qualify
- Ages
- 10 to 18 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult
Key inclusion criteria (3 listed)
- Good general health
- Aged 10 to 18 yrs (females: Tanner stage II-V;and males:testes size>6ml)
- IGT based on 2-hr plasma glucose>140mg/dl and <200mg/dl during an OGTT.
Key exclusion criteria (7 listed)
- Baseline creatinine>1.0mg
- AST and ALT>2.5 ULN
- Anemia (Hct<30)
- Pregnancy (females must have a negative urine pregnancy test during the study)
- Cardiac or pulmonary or other significant chronic illness
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 |
|---|---|---|
| RosiglitazoneAlso: Avandia2mg to begin then 4mg, twice daily for 4 months | Drug | 1 |
| PlaceboSubject receives placebo. | Drug | 2 |
Primary outcome
Mean Percent Change From Baseline in Whole-body Insulin Sensitivity
Time frame: 4 months
This describes the percent changes in insulin sensitivity. Insulin sensitivity was expressed as whole body insulin sensitivity index (WBISI) which is based on the values of insulin (microunits per milliliter) and glucose (milligrams per deciliter) obtained from the OGTT and the corresponding fasting values.The formula is: WBISI=10.000/square root of (fasting glucose x fasting insulin)x(mean glucose x mean insulin).
Mean Percent Change in Visceral-to-subcutaneous Abdominal Fat
Time frame: 4 months
This describes the percent changes of the ratio between visceral and subcutaneous abdominal fat.
Percentage of Subjects Who Converted Impaired Glucose Tolerance (IGT) to Normal Glucose Tolerance (NGT)
Time frame: 4 months
This refers to the number of subjects that converted from IGT to NGT. NGT is defined as fasting glucose lower than 100 mg/dl and 2 hours glucose lower than 140 mg/dl. IGT is defined as 2 hours glucose higher than 140 mg/dl.
Mean Percent Change From Baseline in Hepatic Fat Fraction (HFF)
Time frame: 4 months
It refers to the percent changes of hepatic fat content.
1 secondary outcome
Mean Percent Change From Baseline in Adiponectin
Time frame: 4 months
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 22 Jul 2013.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
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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.
Sonia Caprio, MD principal investigator
Yale School of Medicine Department of Pediatric Endocrinology
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Rosiglitazone in people with Obesity and Impaired Glucose Tolerance, run by Yale University at 1 site in United States.
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 7 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 22 Jul 2013. 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 United States. 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.
Are results available for this study?
Yes. Results are posted in the registry (first posted 19 Apr 2013). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
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?
Mean Percent Change From Baseline in Whole-body Insulin Sensitivity (time frame: 4 months). 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?
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 22 Jul 2013.