Study of Post-meal Blood Sugar Peaks in Association With Vascular Disease in Childhood Obesity
Condition: Pediatric Obesity; Insulin Resistance; Impaired Glucose Tolerance; Cardiovascular Disease
MeSH terms: Cardiovascular Diseases; Vascular Diseases; Obesity; Insulin Resistance; Pediatric Obesity; Glucose Intolerance
Intervention: Acarbose
Intervention description: 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.
Intervention MeSH terms: Acarbose
Phase: Phase 4
Study type: Interventional
Primary purpose: Treatment
Intervention model: Single Group Assignment
Masking: None (Open Label)
Enrollment: 23.0
Sex: All
Minimum age: 12 Years
Maximum age: 25 Years
Healthy volunteers: Accepts Healthy Volunteers
Keywords: Pediatric Obesity; Insulin Resistance; Glucose Tolerance; Adolescents; Acarbose; Continuous Glucose Monitoring (CGMS); Endothelial Dysfunction

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.
    

Eligibility criteria:

        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