Pediatric ObesityPhase 4NCT00846521
Study of Post-meal Blood Sugar Peaks in Association With Vascular Disease in Childhood Obesity
A Phase 4 study testing Acarbose in people with Pediatric Obesity and Insulin Resistance, run by Yale University at 1 site in United States.
Trial summary
The main purpose of this study is to determine whether treatment with acarbose attenuates post-prandial glycemic excursions in non-diabetic/pre-diabetic obese children as determined by continuous glucose monitoring systems (CGMS). Read more about this study
- Who is it for?
- Ages 12 to 25 yearsHealthy volunteers can take part
- Conditions the study is for
- Pediatric Obesity, Insulin Resistance, Impaired Glucose Tolerance
- What is being tested?
- Acarbose
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 23 participants
- Where
- 1 siteUnited States
- Study dates
- Sep 2006to Sep 2008
- Phase
- Phase 4
- 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 12 to 25 years
- All sexes
- Healthy volunteers accepted
- Child, Adult
Who may be able to join
- Obesity (BMI > 97%tile for age and sex matched normative data)
- Good general health, taking no medication on a chronic basis
- Age 12-19 yrs, in puberty (girls: breast: Tanner stage II to V, boys: testicular volume >6ml)
- Girls who are sexually active must use adequate birth control methods(such as barrier method or oral contraception) and must have a negative pregnancy test
- Normal liver function tests
- Lean (BMI < 85%tile for age and sex matched normative data)
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- Good general health, taking no medication on a chronic basis
- Age 12-25 yrs, in puberty (girls: breast: Tanner stage II to V, boys: testicular volume >6ml)
- Girls who are sexually active must use adequate birth control methods (such as barrier method or oral contraception) and must have a negative pregnancy test
Who cannot join
- Raynaud's syndrome
- Pregnancy or breastfeeding mothers
- Smokers
- Anemia (Hct < 35)
- Baseline creatinine > 1.0 mg
- Abnormal liver transaminases > 1.5X the upper limit of normal
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- Presence of endocrinopathies (Cushing syndrome, hypothyroidism)
- Presence or history of gastrointestinal disorders (Inflammatory bowl disease, irritable bowl disease, hernia, ileus)
- Presence of significant chronic illness of any kind
- Drug therapy (examples of commonly occurring drug therapy include any drugs to treat asthma, hypertension, dyslipidemia, insulin resistance, depression)
- Psychiatric disorders
- History of substance abuse (including anorexic agents)
- Control Subjects:
- Raynaud's syndrome
- Pregnancy or breastfeeding mothers
- Smokers
- Presence of endocrinopathies (Cushing syndrome, hypothyroidism Presence of significant chronic illness of any kind
- Drug therapy (examples of commonly occurring drug therapy include any drugs to treat asthma, dyslipidemia, hypertension, depression)
- Psychiatric disorders
- History of substance abuse
- First degree relative with either T1DM or T2DM
- Presence of acanthosis nigricans
Trial locations and contacts
1 site in 1 country.
United States1 site
Yale School of Medicine
New Haven, Connecticut, 06511
About this study
Official title: Postprandial Glycemia in Association With Vascular Disease in Childhood Obesity
The main purpose of this study is to determine whether treatment with acarbose attenuates post-prandial glycemic excursions in non-diabetic/pre-diabetic obese children as determined by continuous glucose monitoring systems (CGMS). To this effect the current pilot study involves a 6 week intervention with acarbose given to all subjects with either impaired glucose tolerance or an area under the curve of >130 mg/dl during the screening oral glucose tolerance test. Three consecutive days of CGMS are then compared to before and during the intervention. The secondary objective addressed in this protocol is the collection of baseline measures of endothelial function in obese and lean children. Even though the duration of acarbose treatment may be too short to demonstrate a vascular effect, the pre and post intervention data would serve as preliminary data for anticipated future studies that assess the vascular effect of reduced post-prandial blood glucose levels.
Read the detailed description
We are particularly interested in examining whether acarbose lowered the percentage of glucose excursions ≥ 140 mg/dl in a real-life, home environment. At baseline, subjects underwent an oral glucose tolerance test (OGTT) and 72 hr of out-patient continuous glucose monitoring. They were treated with acarbose (50 mg with meals three times daily) for 6 weeks and repeat 72 hr CGMS profiles were obtained at the end of the study.
- Being tested
- Acarbose
- Keywords
- Pediatric Obesity, Insulin Resistance, Glucose Tolerance, Adolescents, Acarbose, Continuous Glucose Monitoring (CGMS), Endothelial Dysfunction
- Medical subject headings
- Pediatric Obesity, Insulin Resistance, Glucose Intolerance, Cardiovascular Diseases
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
AcarboseDrug
Also called Precose
At baseline, subjects underwent an OGTT and 72 hr of out-patient continuous glucose monitoring. They were treated with acarbose (50 mg with meals three times daily) for 6 weeks and repeat 72 hr CGMS profiles were obtained at the end of the study.
| Study group | Role | What they receive |
|---|---|---|
| Acarbose | Experimental | At baseline, subjects underwent an OGTT and 72 hr of out-patient continuous glucose monitoring. They were treated with acarbose (50 mg with meals three times daily) for 6 weeks and repeat 72 hr CGMS profiles were obtained at the end of the study. Receives: Drug: Acarbose |
What is being measured
The primary outcome is the main question the study is designed to answer.
Mean Percentage of Glucose Values ≥ 140 mg/dl Over 72 Hours of Glucose Readings Measured With a Continuous Glucose Monitor
Measured: At baseline (before treatment)
Mean Percentage of Glucose Values ≥ 140 mg/dl Over 72 Hours of Glucose Readings Measured With a Continuous Glucose Monitor
Measured: After 6 Weeks (post treatment)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted18 Feb 2009 (estimated)
- Study startSep 2006
- Primary completionSep 2008
- Study completionSep 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 Pediatric 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 4
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 23 participants (actual)
Sponsor and investigators
- Lead sponsor
- Yale University
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Tania S Burgert, MD, Principal investigator, Yale University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00846521
- Sponsor's protocol ID
- 0603001202
- Other IDs
- 5K23DK74439-3, 5K23DK074439
- Status last verified
- Apr 2013
- First submitted
- 16 Feb 2009
- Last updated
- 1 May 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 1 May 2013. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Postprandial Glycemia in Association With Vascular Disease in Childhood Obesity
- ClinicalTrials.gov ID
- NCT00846521
- Acronym / sponsor ID
- 0603001202
- Keywords
- Pediatric Obesity, Insulin Resistance, Glucose Tolerance, Adolescents, Acarbose, Continuous Glucose Monitoring (CGMS), Endothelial Dysfunction
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Terminated
- Enrolment
- 23 participants (actual)
- Lead sponsor
- Yale UniversityUniversity, hospital or other
- Collaborators
- National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)
- Study start
- Sep 2006
- Primary completion
- Sep 2008 (actual)
- Study completion
- Sep 2008 (actual)
- First posted
- 18 Feb 2009 (estimated)
- Results
- Posted 1 May 2013
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The main purpose of this study is to determine whether treatment with acarbose attenuates post-prandial glycemic excursions in non-diabetic/pre-diabetic obese children as determined by continuous glucose monitoring systems (CGMS). To this effect the current pilot study involves a 6 week intervention with acarbose given to all subjects with either impaired glucose tolerance or an area under the curve of >130 mg/dl during the screening oral glucose tolerance test. Three consecutive days of CGMS are then compared to before and during the intervention. The secondary objective addressed in this protocol is the collection of baseline measures of endothelial function in obese and lean children. Even though the duration of acarbose treatment may be too short to demonstrate a vascular effect, the pre and post intervention data would serve as preliminary data for anticipated future studies that assess the vascular effect of reduced post-prandial blood glucose levels.
Detailed description
We are particularly interested in examining whether acarbose lowered the percentage of glucose excursions ≥ 140 mg/dl in a real-life, home environment. At baseline, subjects underwent an oral glucose tolerance test (OGTT) and 72 hr of out-patient continuous glucose monitoring. They were treated with acarbose (50 mg with meals three times daily) for 6 weeks and repeat 72 hr CGMS profiles were obtained at the end of the study.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Acarbose | Experimental | Drug: AcarboseAt baseline, subjects underwent an OGTT and 72 hr of out-patient continuous glucose monitoring. They were treated with acarbose (50 mg with meals three times daily) for 6 weeks and repeat 72 hr CGMS profiles were obtained at the end of the study. |
Who may qualify
- Ages
- 12 to 25 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child, Adult
Key inclusion criteria (9 listed)
- Obesity (BMI > 97%tile for age and sex matched normative data)
- Good general health, taking no medication on a chronic basis
- Age 12-19 yrs, in puberty (girls: breast: Tanner stage II to V, boys: testicular volume >6ml)
- Girls who are sexually active must use adequate birth control methods(such as barrier method or oral contraception) and must have a negative pregnancy test
- Normal liver function tests
Key exclusion criteria (22 listed)
- Raynaud's syndrome
- Pregnancy or breastfeeding mothers
- Smokers
- Anemia (Hct < 35)
- Baseline creatinine > 1.0 mg
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 |
|---|---|---|
| AcarboseAlso: PrecoseAt baseline, subjects underwent an OGTT and 72 hr of out-patient continuous glucose monitoring. They were treated with acarbose (50 mg with meals three times daily) for 6 weeks and repeat 72 hr CGMS profiles were obtained at the end of the study. | Drug | Acarbose |
Primary outcome
Mean Percentage of Glucose Values ≥ 140 mg/dl Over 72 Hours of Glucose Readings Measured With a Continuous Glucose Monitor
Time frame: At baseline (before treatment)
Mean Percentage of Glucose Values ≥ 140 mg/dl Over 72 Hours of Glucose Readings Measured With a Continuous Glucose Monitor
Time frame: After 6 Weeks (post treatment)
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 1 May 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.
Tania S Burgert, MD principal investigator
Yale University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing Acarbose in people with Pediatric Obesity and Insulin Resistance, 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 9 inclusion and 22 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: stopped early, as of the sponsor's last update on 1 May 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. 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 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Yes. Results are posted in the registry (first posted 1 May 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 Percentage of Glucose Values ≥ 140 mg/dl Over 72 Hours of Glucose Readings Measured With a Continuous Glucose Monitor (time frame: At baseline (before treatment)). The study lists 2 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 1 May 2013.