Ignite Creation Date:
2024-05-05 @ 9:43 PM
Last Modification Date:
2024-10-26 @ 10:08 AM
Study NCT ID:
NCT00940966
Status:
COMPLETED
Last Update Posted:
2015-02-03
First Post:
2009-07-15
Brief Title:
A Pilot Study to Determine the Efficacy of a Low Carbohydrate Diet in Treatment of Adolescents With Metabolic Syndrome
Sponsor:
CAMC Health System
Organization:
CAMC Health System
Study Overview
Official Title:
A Pilot Study to Determine the Efficacy of a Low Carbohydrate Diet in Treatment of Adolescents With Metabolic Syndrome
Status:
COMPLETED
Status Verified Date:
2015-02
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
The purpose of this study is to determine the effectiveness of two different non-energy restricted controlled carbohydrate programs with the American Diabetes Associations diet on glycosylated hemoglobin and other diabetes risk factors in obese adolescents with metabolic syndrome a constellation of symptoms associated with the development of type 2 diabetes and cardiovascular disease
Detailed Description:
The purpose of this study is to determine the effectiveness of two different non-energy restricted controlled carbohydrate programs with the American Diabetes Associations diet on glycosylated hemoglobin and other diabetes risk factors in obese adolescents with metabolic syndrome a constellation of symptoms associated with the development of type 2 diabetes and cardiovascular disease
We plan to address the following issues
1 To test the hypothesis that a controlled carbohydrate nutrition plan will be superior to the standard ADA diet in controlling blood sugar as measured by glycosylated hemoglobin HbA1C decreasing cardiovascular risk factors Serum Lipid Levels Blood Pressure and decreasing weight in adolescents with metabolic syndrome
2 To evaluate the tolerability of a non-energy restricted very-low carbohydrate diet in these patients as measured by the SF-10 for Children the Brief Symptom Inventory BSI and a scaled questionnaire regarding side effects
3 To compare two different maintenance programs in the group who receive the non- energy restricted very-low carbohydrate diet and compare each group to the group
We plan to address the following issues
1 To test the hypothesis that a controlled carbohydrate nutrition plan will be superior to the standard ADA diet in controlling blood sugar as measured by glycosylated hemoglobin HbA1C decreasing cardiovascular risk factors Serum Lipid Levels Blood Pressure and decreasing weight in adolescents with metabolic syndrome
2 To evaluate the tolerability of a non-energy restricted very-low carbohydrate diet in these patients as measured by the SF-10 for Children the Brief Symptom Inventory BSI and a scaled questionnaire regarding side effects
3 To compare two different maintenance programs in the group who receive the non- energy restricted very-low carbohydrate diet and compare each group to the group
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None