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

This study has been terminated.
Sponsor:
Collaborator:
Information provided by (Responsible Party):
Yale University
ClinicalTrials.gov Identifier:
NCT00846521
First received: February 16, 2009
Last updated: April 29, 2013
Last verified: April 2013
  Purpose

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.


Condition Intervention Phase
Pediatric Obesity
Insulin Resistance
Impaired Glucose Tolerance
Cardiovascular Disease
Drug: Acarbose
Phase 4

Study Type: Interventional
Study Design: Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: Postprandial Glycemia in Association With Vascular Disease in Childhood Obesity

Resource links provided by NLM:


Further study details as provided by Yale University:

Primary Outcome Measures:
  • Mean Percentage of Glucose Values ≥ 140 mg/dl Over 72 Hours of Glucose Readings Measured With a Continuous Glucose Monitor [ Time Frame: At baseline (before treatment) ] [ Designated as safety issue: No ]
  • Mean Percentage of Glucose Values ≥ 140 mg/dl Over 72 Hours of Glucose Readings Measured With a Continuous Glucose Monitor [ Time Frame: After 6 Weeks (post treatment) ] [ Designated as safety issue: No ]

Enrollment: 23
Study Start Date: September 2006
Study Completion Date: September 2008
Primary Completion Date: September 2008 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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 Name: Precose

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.

  Eligibility

Ages Eligible for Study:   12 Years to 25 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   Yes
Criteria

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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00846521

Locations
United States, Connecticut
Yale School of Medicine
New Haven, Connecticut, United States, 06511
Sponsors and Collaborators
Yale University
Investigators
Principal Investigator: Tania S Burgert, MD Yale School of Medicine
  More Information

No publications provided

Responsible Party: Yale University
ClinicalTrials.gov Identifier: NCT00846521     History of Changes
Other Study ID Numbers: 0603001202, 5K23DK74439-3
Study First Received: February 16, 2009
Results First Received: March 7, 2013
Last Updated: April 29, 2013
Health Authority: United States: Institutional Review Board

Keywords provided by Yale University:
Pediatric Obesity
Insulin Resistance
Glucose Tolerance
Adolescents
Acarbose
Continuous Glucose Monitoring (CGMS)
Endothelial Dysfunction

Additional relevant MeSH terms:
Cardiovascular Diseases
Insulin Resistance
Obesity
Vascular Diseases
Glucose Intolerance
Pediatric Obesity
Hyperinsulinism
Glucose Metabolism Disorders
Metabolic Diseases
Overnutrition
Nutrition Disorders
Overweight
Body Weight
Signs and Symptoms
Hyperglycemia
Acarbose
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action
Pharmacologic Actions
Hypoglycemic Agents
Physiological Effects of Drugs

ClinicalTrials.gov processed this record on August 21, 2014