Clinical trial NCT00846521: 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
Overall status: TERMINATED
Phase: PHASE4
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
Lead sponsor: Yale University
Sponsor class: OTHER
Collaborators: name: National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)
First posted: 2009-02-18
Enrollment: 23
Sex: ALL
Minimum age (years): 12
Maximum age (years): 25
Standard ages: CHILD
ADULT
Accepts healthy volunteers: yes
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

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.

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

Primary outcomes:
measure: Mean Percentage of Glucose Values ≥ 140 mg/dl Over 72 Hours of Glucose Readings Measured With a Continuous Glucose Monitor
timeFrame: At baseline (before treatment)
measure: Mean Percentage of Glucose Values ≥ 140 mg/dl Over 72 Hours of Glucose Readings Measured With a Continuous Glucose Monitor
timeFrame: After 6 Weeks (post treatment)
Secondary outcomes:
Other outcomes:
Locations:
city: New Haven
country: United States
facility: Yale School of Medicine
state: Connecticut
Study officials:
affiliation: Yale University
name: Tania S Burgert, MD
role: PRINCIPAL_INVESTIGATOR
References: