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| ID | Type | Description | Link |
|---|---|---|---|
| 5K23DK74439-3 | |||
| 5K23DK074439 | U.S. NIH Grant/Contract | View source |
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| Name | Class |
|---|---|
| National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK) | NIH |
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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Acarbose | Experimental | 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. |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Acarbose | Drug | 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 | Description | Time Frame |
|---|---|---|
| Mean Percentage of Glucose Values ≥ 140 mg/dl Over 72 Hours of Glucose Readings Measured With a Continuous Glucose Monitor | At baseline (before treatment) | |
| 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) |
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Obese Subjects:
Inclusion Criteria:
Exclusion Criteria:
Control Subjects:
Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Tania S Burgert, MD | Yale University | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Yale School of Medicine | New Haven | Connecticut | 06511 | United States |
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| ID | Title | Description |
|---|---|---|
| FG000 | 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. |
| Title | Milestones | Reasons Not Completed | ||||||||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
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|
Baseline analysis was only done on subjects who completed the study
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| ID | Title | Description |
|---|---|---|
| BG000 | 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. |
| Units | Counts |
|---|---|
| Participants |
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| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age Continuous | Mean |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | |||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | Mean Percentage of Glucose Values ≥ 140 mg/dl Over 72 Hours of Glucose Readings Measured With a Continuous Glucose Monitor | The number of participants who completed the study were analyzed | Posted | Mean | Standard Deviation | percentage of glucose excursions ≥ 140 | At baseline (before treatment) |
|
|
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Acarbose Administration | 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. |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Tania Burgurt, MD | Yale University School of Medicine | 203-785-7152 | tania.burgurt@yale.edu |
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| ID | Term |
|---|---|
| D063766 | Pediatric Obesity |
| D007333 | Insulin Resistance |
| D018149 | Glucose Intolerance |
| D002318 | Cardiovascular Diseases |
| ID | Term |
|---|---|
| D009765 | Obesity |
| D050177 | Overweight |
| D044343 | Overnutrition |
| D009748 | Nutrition Disorders |
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| ID | Term |
|---|---|
| D020909 | Acarbose |
| ID | Term |
|---|---|
| D014312 | Trisaccharides |
| D009844 | Oligosaccharides |
| D011134 | Polysaccharides |
| D002241 | Carbohydrates |
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|
| years |
|
| Sex: Female, Male | Count of Participants | Participants |
|
|
|
| Primary | Mean Percentage of Glucose Values ≥ 140 mg/dl Over 72 Hours of Glucose Readings Measured With a Continuous Glucose Monitor | The number of participants who completed the study were analyzed | Posted | Mean | Standard Deviation | percentage of glucose excursions ≥ 140 | After 6 Weeks (post treatment) |
|
|
|
| 0 |
| 12 |
| 0 |
| 12 |
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| D009750 |
| Nutritional and Metabolic Diseases |
| D001835 | Body Weight |
| D012816 | Signs and Symptoms |
| D013568 | Pathological Conditions, Signs and Symptoms |
| D006946 | Hyperinsulinism |
| D044882 | Glucose Metabolism Disorders |
| D008659 | Metabolic Diseases |
| D006943 | Hyperglycemia |