Now Available for Public Comment: Notice of Proposed Rulemaking (NPRM) for FDAAA 801 and NIH Draft Reporting Policy for NIH-Funded Trials

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

February 16, 2009
April 29, 2013
September 2006
September 2008   (final data collection date for primary outcome measure)
  • 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 ]
The effectiveness of acarbose to attenuate post-prandial glycemic excursions as determined by a continuous glucose monitoring system (CGMS). [ Time Frame: Pre- and post-intervention (0 and 6-7 weeks). ] [ Designated as safety issue: No ]
Complete list of historical versions of study NCT00846521 on ClinicalTrials.gov Archive Site
Not Provided
Cardiovascular risk parameters will be assessed via flow mediated vasodilation, peripheral arterial tonometry and biochemical markers of vascular health. [ Time Frame: At 0 weeks (baseline) and 6-7 weeks. ] [ Designated as safety issue: No ]
Not Provided
Not Provided
 
Study of Post-meal Blood Sugar Peaks in Association With Vascular Disease in Childhood Obesity
Postprandial Glycemia in Association With Vascular Disease in Childhood Obesity

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.

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.

Interventional
Phase 4
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
  • Pediatric Obesity
  • Insulin Resistance
  • Impaired Glucose Tolerance
  • Cardiovascular Disease
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
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.
Intervention: Drug: Acarbose
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Terminated
23
September 2008
September 2008   (final data collection date for primary outcome measure)

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
Both
12 Years to 25 Years
Yes
Contact information is only displayed when the study is recruiting subjects
United States
 
NCT00846521
0603001202, 5K23DK74439-3
No
Yale University
Yale University
National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)
Principal Investigator: Tania S Burgert, MD Yale School of Medicine
Yale University
April 2013

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP