Status:
TERMINATED
Study of Post-meal Blood Sugar Peaks in Association With Vascular Disease in Childhood Obesity
Lead Sponsor:
Yale University
Collaborating Sponsors:
National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)
Conditions:
Pediatric Obesity
Insulin Resistance
Eligibility:
All Genders
12-25 years
Phase:
PHASE4
Brief 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 gluc...
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 ...
Eligibility Criteria
Inclusion
- Obese Subjects:
- 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
- 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
Key Trial Info
Start Date :
September 1 2006
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
September 1 2008
Estimated Enrollment :
23 Patients enrolled
Trial Details
Trial ID
NCT00846521
Start Date
September 1 2006
End Date
September 1 2008
Last Update
May 1 2013
Active Locations (1)
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1
Yale School of Medicine
New Haven, Connecticut, United States, 06511