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

NCT00846521 | Terminated Phase 4 Results

• 3 other identifiers: 06030012025K23DK74439-35K23DK074439
• Study Type: interventional
• Target: 23
• Locations: 1 country
• Sites: 1

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.

Conditions

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

Keywords

Pediatric Obesity; Insulin Resistance; Glucose Tolerance; Adolescents; Acarbose; Continuous Glucose Monitoring (CGMS); Endothelial Dysfunction

Outcome Measures

Primary Outcomes (2)

• 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)

Study Arms (1)

Acarbose

EXPERIMENTAL

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

Interventions

Acarbose 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.

Also known as: Precose

Acarbose

Eligibility Criteria

• Age: 12 Years - 25 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Child (0-17), Adult (18-64)

You may qualify if:

• 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

You may not qualify if:

• 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:
• Lean (BMI \< 85%tile for age and sex matched normative data)
• Good general health, taking no medication on a chronic basis

Sponsors & Collaborators

• Yale University: lead
• National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK): collaborator

Study Sites (1)

Yale School of Medicine

New Haven, Connecticut, 06511, United States

Location

MeSH Terms

Conditions

Pediatric Obesity; Insulin Resistance; Glucose Intolerance; Cardiovascular Diseases

Interventions

Acarbose

Condition Hierarchy (Ancestors)

Obesity; Overweight; Overnutrition; Nutrition Disorders; Nutritional and Metabolic Diseases; Body Weight; Signs and Symptoms; Pathological Conditions, Signs and Symptoms; Hyperinsulinism; Glucose Metabolism Disorders; Metabolic Diseases; Hyperglycemia

Intervention Hierarchy (Ancestors)

Trisaccharides; Oligosaccharides; Polysaccharides; Carbohydrates

Results Point of Contact

• Title: Tania Burgurt, MD
• Organization: Yale University School of Medicine

tania.burgurt@yale.edu

203-785-7152

Study Officials

• Tania S Burgert, MD

  Yale University

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: Yes

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: February 16, 2009
• First Posted: February 18, 2009
• Study Start: September 1, 2006
• Primary Completion: September 1, 2008
• Study Completion: September 1, 2008
• Last Updated: May 1, 2013
• Results First Posted: May 1, 2013

Record last verified: 2013-04

Locations

US (1)