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

• Sponsor: Yale University (Other)
• Overall Status: Terminated
• CT.gov ID: NCT00846521
• Collaborator: National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK) (NIH)
• Enrollment: 23
• Location: 1
• Arm: 1
• Duration (Months): 24
• Patients Per Site Per Month: 1

Study Details

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.

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

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.

Study Design

• Study Type: Interventional
• Actual Enrollment: 23 participants
• Allocation: N/A
• Intervention Model: Single Group Assignment
• Masking: None (Open Label)
• Primary Purpose: Treatment
• Official Title: Postprandial Glycemia in Association With Vascular Disease in Childhood Obesity
• Study Start Date: Sep 1, 2006
• Actual Primary Completion Date: Sep 1, 2008
• Actual Study Completion Date: Sep 1, 2008

Arms and Interventions

Arm	Intervention/Treatment
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 Names: Precose

Outcome Measures

Primary Outcome Measures

1. Mean Percentage of Glucose Values ≥ 140 mg/dl Over 72 Hours of Glucose Readings Measured With a Continuous Glucose Monitor [At baseline (before treatment)]

2. 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)]

Eligibility Criteria

Criteria

• Ages Eligible for Study: 12 Years to 25 Years
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: Yes

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

Locations

	Site	City	State	Country	Postal Code
1	Yale School of Medicine	New Haven	Connecticut	United States	06511

Sponsors and Collaborators

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

Investigators

• Principal Investigator: Tania S Burgert, MD, Yale School of Medicine

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

• Responsible Party: Yale University
• ClinicalTrials.gov Identifier: NCT00846521
• Other Study ID Numbers: 0603001202; 5K23DK74439-3
• First Posted: Feb 18, 2009
• Last Update Posted: May 1, 2013
• Last Verified: Apr 1, 2013

• 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; Vascular Diseases; Obesity; Insulin Resistance; Pediatric Obesity; Glucose Intolerance; Acarbose

Study Results

Participant Flow

Arm/Group Title	Acarbose Administration
Arm/Group Description	Acarbose : Subjects assigned to treatment will receive an exact supply of Acarbose to cover the initial 5 weeks of intervention. The medication will be distributed by the investigational pharmacy. Subjects will be instructed on the dosing schedule as follows (due to potential gastrointestinal side effects, the dose will be increased incrementally to desired levels). Tablets (dose) of acarbose: Week 1 - 25 mg once a day (with dinner); Week 2 - 50 mg once a day (with dinner); Week 3 - 25 mg with breakfast and 50 mg with dinner; Week 4 - 50 mg with breakfast, 25 mg with lunch and 50 mg with dinner; Week 5-7 - 50 mg with breakfast, 50 mg with lunch and 50 mg with dinner.
Period Title: Overall Study
STARTED	23
COMPLETED	12
NOT COMPLETED	11

Baseline Characteristics

Arm/Group Title	Acarbose Administration
Arm/Group Description	Acarbose : Subjects assigned to treatment will receive an exact supply of Acarbose to cover the initial 5 weeks of intervention. The medication will be distributed by the investigational pharmacy. Subjects will be instructed on the dosing schedule as follows (due to potential gastrointestinal side effects, the dose will be increased incrementally to desired levels). Tablets (dose) of acarbose: Week 1 - 25 mg once a day (with dinner); Week 2 - 50 mg once a day (with dinner); Week 3 - 25 mg with breakfast and 50 mg with dinner; Week 4 - 50 mg with breakfast, 25 mg with lunch and 50 mg with dinner; Week 5-7 - 50 mg with breakfast, 50 mg with lunch and 50 mg with dinner.
Overall Participants	12
Age (years) [Mean (Standard Deviation) ]
Mean (Standard Deviation) [years]	15.2 (1.1)
Sex: Female, Male (Count of Participants)
Female	5 41.7%
Male	7 58.3%

Outcome Measures

1. Primary Outcome

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)

Outcome Measure Data

Analysis Population Description

The number of participants who completed the study were analyzed

Arm/Group Title	Acarbose Administration
Arm/Group 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
Measure Participants	12
Mean (Standard Deviation) [percentage of glucose excursions ≥ 140]	8 (8)

2. Primary Outcome

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)

Outcome Measure Data

Analysis Population Description

The number of participants who completed the study were analyzed

Arm/Group Title	Acarbose Administration
Arm/Group 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
Measure Participants	12
Mean (Standard Deviation) [percentage of glucose excursions ≥ 140]	2 (5)

Adverse Events

Arm/Group Title	Acarbose Administration
Arm/Group 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.
All Cause Mortality
	Acarbose Administration
	Affected / at Risk (%)	# Events
Total	/ (NaN)
Serious Adverse Events
	Acarbose Administration
	Affected / at Risk (%)	# Events
Total	0/12 (0%)
Other (Not Including Serious) Adverse Events
	Acarbose Administration
	Affected / at Risk (%)	# Events
Total	0/12 (0%)

Limitations/Caveats

[Not Specified]

More Information

Certain Agreements

All Principal Investigators ARE employed by the organization sponsoring the study.

There is NOT an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.