Trial Outcomes & Findings for Study of Post-meal Blood Sugar Peaks in Association With Vascular Disease in Childhood Obesity (NCT NCT00846521)

Results Overview

Recruitment status

TERMINATED

Study phase

PHASE4

Target enrollment

23 participants

Primary outcome timeframe

At baseline (before treatment)

Results posted on

2013-05-01

Participant milestones
Measure	Acarbose Administration 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 Study STARTED	23
Overall Study COMPLETED	12
Overall Study NOT COMPLETED	11

Reasons for withdrawal
Measure	Acarbose Administration 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 Study Withdrawal by Subject	5
Overall Study Did not meet OGTT/ CGMS criteria	5
Overall Study Protocol Violation	1

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

Baseline characteristics by cohort
Measure	Acarbose Administration n=12 Participants 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.
Age Continuous	15.2 years STANDARD_DEVIATION 1.1 • n=5 Participants
Sex: Female, Male Female	5 Participants n=5 Participants
Sex: Female, Male Male	7 Participants n=5 Participants

Timeframe: At baseline (before treatment)

Population: The number of participants who completed the study were analyzed

Outcome measures
Measure	Acarbose Administration n=12 Participants 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
Mean Percentage of Glucose Values ≥ 140 mg/dl Over 72 Hours of Glucose Readings Measured With a Continuous Glucose Monitor	8 percentage of glucose excursions ≥ 140 Standard Deviation 8

Timeframe: After 6 Weeks (post treatment)

Population: The number of participants who completed the study were analyzed

Outcome measures
Measure	Acarbose Administration n=12 Participants 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
Mean Percentage of Glucose Values ≥ 140 mg/dl Over 72 Hours of Glucose Readings Measured With a Continuous Glucose Monitor	2 percentage of glucose excursions ≥ 140 Standard Deviation 5

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

Adverse event data not reported

Adverse event data not reported

Yale University School of Medicine

Phone: 203-785-7152