search
Back to results

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

Primary Purpose

Pediatric Obesity, Insulin Resistance, Impaired Glucose Tolerance

Status
Terminated
Phase
Phase 4
Locations
United States
Study Type
Interventional
Intervention
Acarbose
Sponsored by
Yale University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Pediatric Obesity focused on measuring Pediatric Obesity, Insulin Resistance, Glucose Tolerance, Adolescents, Acarbose, Continuous Glucose Monitoring (CGMS), Endothelial Dysfunction

Eligibility Criteria

12 Years - 25 Years (Child, Adult)All SexesAccepts Healthy Volunteers

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

Sites / Locations

  • Yale School of Medicine

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

Acarbose

Arm Description

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.

Outcomes

Primary Outcome Measures

Mean Percentage of Glucose Values ≥ 140 mg/dl Over 72 Hours of Glucose Readings Measured With a Continuous Glucose Monitor
Mean Percentage of Glucose Values ≥ 140 mg/dl Over 72 Hours of Glucose Readings Measured With a Continuous Glucose Monitor

Secondary Outcome Measures

Full Information

First Posted
February 16, 2009
Last Updated
April 29, 2013
Sponsor
Yale University
Collaborators
National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)
search

1. Study Identification

Unique Protocol Identification Number
NCT00846521
Brief Title
Study of Post-meal Blood Sugar Peaks in Association With Vascular Disease in Childhood Obesity
Official Title
Postprandial Glycemia in Association With Vascular Disease in Childhood Obesity
Study Type
Interventional

2. Study Status

Record Verification Date
April 2013
Overall Recruitment Status
Terminated
Study Start Date
September 2006 (undefined)
Primary Completion Date
September 2008 (Actual)
Study Completion Date
September 2008 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Yale University
Collaborators
National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)

4. Oversight

Data Monitoring Committee
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Pediatric Obesity, Insulin Resistance, Impaired Glucose Tolerance, Cardiovascular Disease
Keywords
Pediatric Obesity, Insulin Resistance, Glucose Tolerance, Adolescents, Acarbose, Continuous Glucose Monitoring (CGMS), Endothelial Dysfunction

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 4
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
23 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Acarbose
Arm Type
Experimental
Arm Description
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
Intervention Name(s)
Acarbose
Other Intervention Name(s)
Precose
Intervention Description
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.
Primary Outcome Measure Information:
Title
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)
Title
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)

10. Eligibility

Sex
All
Minimum Age & Unit of Time
12 Years
Maximum Age & Unit of Time
25 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility 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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Tania S Burgert, MD
Organizational Affiliation
Yale School of Medicine
Official's Role
Principal Investigator
Facility Information:
Facility Name
Yale School of Medicine
City
New Haven
State/Province
Connecticut
ZIP/Postal Code
06511
Country
United States

12. IPD Sharing Statement

Learn more about this trial

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

We'll reach out to this number within 24 hrs