Study of Post-meal Blood Sugar Peaks in Association With Vascular Disease in Childhood Obesity

Phase 4

Terminated

Conditions: Pediatric Obesity
Insulin Resistance
Impaired Glucose Tolerance
Cardiovascular Disease

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 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.

Recruitment & Eligibility

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

Arm && Interventions

Group	Intervention	Description
Acarbose	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.

Primary Outcome Measures

Name	Time	Method
Mean Percentage of Glucose Values ≥ 140 mg/dl Over 72 Hours of Glucose Readings Measured With a Continuous Glucose Monitor	After 6 Weeks (post treatment)

Secondary Outcome Measures