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

NCT ID: NCT00846521

Last Updated: 2013-05-01

Basic Information

• Recruitment Status: TERMINATED
• Clinical Phase: PHASE4
• Total Enrollment: 23 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2006-09-30
• Study Completion Date: 2008-09-30

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.

Conditions

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

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

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.

Group Type: EXPERIMENTAL

Acarbose

Intervention Type: DRUG

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.

Interventions

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.

Intervention Type: DRUG

Other Intervention Names

Precose

Eligibility Criteria

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

• 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
• 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:

• 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

• Minimum Eligible Age: 12 Years
• Maximum Eligible Age: 25 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)

NIH

Sponsor Role: collaborator

Yale University

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Tania S Burgert, MD

Role: PRINCIPAL_INVESTIGATOR

Yale University

Locations

Yale School of Medicine

New Haven, Connecticut, United States

Countries

United States

Other Identifiers

5K23DK74439-3

Identifier Type: -

Identifier Source: secondary_id

5K23DK074439

Identifier Type: NIH

Identifier Source: secondary_id

View Link

0603001202

Identifier Type: -

Identifier Source: org_study_id