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

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.

Study Overview

• Status: Terminated
• Conditions: Cardiovascular Disease; Insulin Resistance; Pediatric Obesity; Impaired Glucose Tolerance
• Intervention / Treatment: Drug: Acarbose

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 Type: Interventional
• Enrollment (Actual): 23
• Phase: Phase 4

Contacts and Locations

Study Locations

• United States
  • Connecticut
    • New Haven, Connecticut, United States, 06511
      • Yale School of Medicine

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 12 years to 25 years (Child, Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
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 Names: Precose

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
Mean Percentage of Glucose Values ≥ 140 mg/dl Over 72 Hours of Glucose Readings Measured With a Continuous Glucose Monitor	At baseline (before treatment)
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)

Collaborators and Investigators

• Sponsor: Yale University
• Collaborators: National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)
• Investigators: Principal Investigator: Tania S Burgert, MD, Yale School of Medicine

Study record dates

Study Major Dates

• Study Start: September 1, 2006
• Primary Completion (Actual): September 1, 2008
• Study Completion (Actual): September 1, 2008

Study Registration Dates

• First Submitted: February 16, 2009
• First Submitted That Met QC Criteria: February 17, 2009
• First Posted (Estimate): February 18, 2009

Study Record Updates

• Last Update Posted (Estimate): May 1, 2013
• Last Update Submitted That Met QC Criteria: April 29, 2013
• Last Verified: April 1, 2013

More Information

Terms related to this study

• Keywords: Adolescents; Insulin Resistance; Acarbose; Endothelial Dysfunction; Pediatric Obesity; Glucose Tolerance; Continuous Glucose Monitoring (CGMS)
• Additional Relevant MeSH Terms: Glucose Metabolism Disorders; Metabolic Diseases; Overnutrition; Nutrition Disorders; Overweight; Body Weight; Hyperinsulinism; Hyperglycemia; Cardiovascular Diseases; Obesity; Vascular Diseases; Pediatric Obesity; Glucose Intolerance; Insulin Resistance; Hypoglycemic Agents; Physiological Effects of Drugs; Molecular Mechanisms of Pharmacological Action; Enzyme Inhibitors; Glycoside Hydrolase Inhibitors; Acarbose
• Other Study ID Numbers: 0603001202; 5K23DK74439-3