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

Cardiovascular Disease Clinical Trial

Official title:

Postprandial Glycemia in Association With Vascular Disease in Childhood Obesity

Clinical Trial Details — Status: Terminated

Administrative data

• NCT number: NCT00846521
• Other study ID #: 0603001202
• Secondary ID: 5K23DK74439-3
• Status: Terminated
• Phase: Phase 4
• First received: February 16, 2009
• Last updated: April 29, 2013
• Start date: September 2006
• Est. completion date: September 2008

Study information

• Verified date: April 2013
• Source: Yale University
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Institutional Review Board
• Study type: Interventional

Clinical Trial 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.

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 information / eligibility

• Status: Terminated
• Enrollment: 23
• Est. completion date: September 2008
• Est. primary completion date: September 2008
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Both
• Age group: 12 Years to 25 Years

Eligibility

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 Design

Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Cardiovascular Disease
• Cardiovascular Diseases
• Glucose Intolerance
• Impaired Glucose Tolerance
• Insulin Resistance
• Obesity
• Pediatric Obesity
• Vascular Diseases

Intervention

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.

Locations

Country	Name	City	State
United States	Yale School of Medicine	New Haven	Connecticut

Sponsors (2)

Lead Sponsor	Collaborator
Yale University	National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Mean Percentage of Glucose Values = 140 mg/dl Over 72 Hours of Glucose Readings Measured With a Continuous Glucose Monitor		At baseline (before treatment)	No
Primary	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)	No