A Pilot Study to Determine the Efficacy of a Low Carbohydrate Diet in Treatment of Adolescents With Metabolic Syndrome
NCT ID: NCT00940966
Last Updated: 2015-02-03
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.
COMPLETED
NA
40 participants
INTERVENTIONAL
2006-07-31
2012-05-31
Brief Summary
Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.
Related Clinical Trials
Explore similar clinical trials based on study characteristics and research focus.
Low-Carbohydrate Dietary Pattern on Glycemic Outcomes Trial
NCT03675360
Diabetes Dietary Study- Low Carbohydrate and Low-Fat Diets in Type 2 Diabetes
NCT00795691
The Effectiveness of Low Carbohydrate Diet in Reducing Polypharmacy for Patients With Type 2 Diabetes Mellitus
NCT03176056
Short-term Effects of Carbohydrate-restricted Diet on Glycemic and Metabolic Control Among Children and Adolescent With Type 1 Diabetes Mellitus
NCT06699485
Canadian Trial of Dietary Carbohydrates in Diabetes
NCT00223574
Detailed Description
Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.
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
Conditions
See the medical conditions and disease areas that this research is targeting or investigating.
Study Design
Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.
RANDOMIZED
PARALLEL
TREATMENT
NONE
Study Groups
Review each arm or cohort in the study, along with the interventions and objectives associated with them.
energy restricted very-low carbohydrate
non-energy restricted ketogenic diet .
energy restricted very-low carbohydrate diet
energy restricted very-low carbohydrate diet
ADA diet
standard ADA diet
standard ADA diet
standard ADA diet
energy restricted very-low carbohydrate diet
energy restricted very-low carbohydrate diet
low glycemic index
restricted ketogenic diet
low glycemic diet
restricted ketogenic diet
Interventions
Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.
standard ADA diet
standard ADA diet
energy restricted very-low carbohydrate diet
energy restricted very-low carbohydrate diet
low glycemic diet
restricted ketogenic diet
Other Intervention Names
Discover alternative or legacy names that may be used to describe the listed interventions across different sources.
Eligibility Criteria
Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.
Inclusion Criteria
Exclusion Criteria
* Subjects currently taking Byetta will be excluded from the study, as a side effect of the drug is weight loss.
* Subjects with familial hypercholesteremia may be excluded if the investigator considers the history to be severe. The data collected from subjects with a HBA1C greater than 12.5 will be analyzed in a separate group, although they will still be randomized to one of the three treatment groups. This is due to the fact that past experience has shown that these individuals run a high risk of being non-compliant with medication use, diet, and exercise plans. Results from this group will be reported separately.
* Subjects who are pregnant or those desiring pregnancy will be excluded, as the safety of this intervention in pregnancy has not been established.
12 Years
18 Years
ALL
No
Sponsors
Meet the organizations funding or collaborating on the study and learn about their roles.
CAMC Health System
OTHER
Responsible Party
Identify the individual or organization who holds primary responsibility for the study information submitted to regulators.
WVU department of pediatrics
Principal Investigators
Learn about the lead researchers overseeing the trial and their institutional affiliations.
Steven Sondike, MD
Role: PRINCIPAL_INVESTIGATOR
WVU Department of Pediatrics
Locations
Explore where the study is taking place and check the recruitment status at each participating site.
Wvu Department of Pediatrics
Charleston, West Virginia, United States
Countries
Review the countries where the study has at least one active or historical site.
Other Identifiers
Review additional registry numbers or institutional identifiers associated with this trial.
06-02-1776
Identifier Type: -
Identifier Source: org_study_id
More Related Trials
Additional clinical trials that may be relevant based on similarity analysis.