NCT00846521

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

• Status: Terminated
• Phase: Phase 4
• Study type: Interventional
• Enrollment: 23 (actual)
• Sponsor: Yale University · Academic / Other
• Sex: All
• Age: 12 Years – 25 Years
• Healthy volunteers: Accepted

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.

Conditions

• Pediatric Obesity
• Insulin Resistance
• Impaired Glucose Tolerance
• Cardiovascular Disease

Interventions

Type	Name	Description
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.

Timeline

• Start date: 2006-09-01
• Primary completion: 2008-09-01
• Completion: 2008-09-01
• First posted: 2009-02-18
• Last updated: 2013-05-01
• Results posted: 2013-05-01

Locations

1 site across 1 country: United States