Study of Post-meal Blood Sugar Peaks in Association With Vascular Disease in Childhood Obesity
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Purpose
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.
| Condition | Intervention | Phase |
|---|---|---|
|
Pediatric Obesity Insulin Resistance Impaired Glucose Tolerance Cardiovascular Disease |
Drug: Acarbose |
Phase 4 |
| Study Type: | Interventional |
| Study Design: | Intervention Model: Single Group Assignment Masking: Open Label Primary Purpose: Treatment |
| Official Title: | Postprandial Glycemia in Association With Vascular Disease in Childhood Obesity |
- 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) ] [ Designated as safety issue: No ]
- 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) ] [ Designated as safety issue: No ]
| Enrollment: | 23 |
| Study Start Date: | September 2006 |
| Study Completion Date: | September 2008 |
| Primary Completion Date: | September 2008 (Final data collection date for primary outcome measure) |
| Arms | Assigned Interventions |
|---|---|
|
Experimental: Acarbose
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.
|
Drug: Acarbose
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.
Other Name: Precose
|
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.
Eligibility| Ages Eligible for Study: | 12 Years to 25 Years |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | Yes |
Obese Subjects:
Inclusion Criteria:
- 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
Exclusion Criteria:
- 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
- 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:
Inclusion Criteria:
- Lean (BMI < 85%tile for age and sex matched normative data)
- 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
Exclusion Criteria:
- 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
Contacts and Locations| United States, Connecticut | |
| Yale School of Medicine | |
| New Haven, Connecticut, United States, 06511 | |
| Principal Investigator: | Tania S Burgert, MD | Yale School of Medicine |
More Information
No publications provided
| Responsible Party: | Yale University |
| ClinicalTrials.gov Identifier: | NCT00846521 History of Changes |
| Other Study ID Numbers: | 0603001202, 5K23DK74439-3 |
| Study First Received: | February 16, 2009 |
| Results First Received: | March 7, 2013 |
| Last Updated: | April 29, 2013 |
| Health Authority: | United States: Institutional Review Board |
Keywords provided by Yale University:
|
Pediatric Obesity Insulin Resistance Glucose Tolerance Adolescents |
Acarbose Continuous Glucose Monitoring (CGMS) Endothelial Dysfunction |
Additional relevant MeSH terms:
|
Cardiovascular Diseases Insulin Resistance Obesity Vascular Diseases Glucose Intolerance Hyperinsulinism Glucose Metabolism Disorders Metabolic Diseases Overnutrition Nutrition Disorders |
Overweight Body Weight Signs and Symptoms Hyperglycemia Acarbose Enzyme Inhibitors Molecular Mechanisms of Pharmacological Action Pharmacologic Actions Hypoglycemic Agents Physiological Effects of Drugs |
ClinicalTrials.gov processed this record on June 18, 2013