Clinical trial NCT03937960: Effect of Low Carbohydrate Versus Low Fat Diet in the Treatment of Dyslipidemia in Obese Children With Metabolic Syndrome
Official title: Effect of Carbohydrate Restricted Versus Standard Low Fat Diet in the Treatment of Dyslipidemia in Children With Metabolic Syndrome
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Metabolic Syndrome
Obesity
Dyslipidemias
Keywords: Dietary intervention
Anthropometric measure
Lipid profile
Augmentation Index
Flow mediated dilation
DXA scan
Nuclear magnetic resonance lipid profile
Lead sponsor: University of Alabama at Birmingham
Sponsor class: OTHER
Collaborators: name: National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)
First posted: 2019-05-06
Enrollment: 30
Sex: ALL
Minimum age (years): 10
Maximum age (years): 18
Standard ages: CHILD
ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: Two-arm, parallel design with children between the ages of 10 - 18 with obesity and metabolic syndrome randomized (15 per group) to reduced-carbohydrate diet or a reduced-fat diet for 8 weeks.

Detailed description: Two-arm, parallel design with participants randomized (15 per group) to reduced-carbohydrate diet or a reduced-fat diet for 8 weeks. Anthropometric evaluations, lab work for lipid levels, insulin and C peptide levels, resting energy expenditure evaluation, DXA scan and cardiovascular markers will occur at baseline during the initial clinic visit. Individual dietary counseling will be provided at baseline and as well as weekly diet-specific support will be provided with a phone call from the PI. Dietary intake will be assessed with weekly food records (weeks 1-8). The return visit on week 8 will include a visit identical to the initial visit except the resting energy expenditure will not be revaluated, and the participants will be asked to answer a questionnaire about the diet they were consuming.

Eligibility criteria: Inclusion Criteria: 3 out of 5 of the following criteria

* Metabolic syndrome with dyslipidemia
* (HDL \<40mg/dL
* Triglyceride (TG) TG\>150mg/dL)
* Glucose intolerance (fasting blood sugar \>100mg/dL)
* Central adiposity (Waist circumference ≥90th percentile or adult cutoff if lower)
* Systolic BP ≥130 mm Hg or diastolic BP ≥85 mm Hg or treatment of previously diagnosed hypertension

Exclusion Criteria:

* Patient on medications known to induce dyslipidemia (systemic steroids, immunosuppressants)
* Pregnancy
* Untreated thyroid disease, heart disease, cancer, kidney disease
* Children on statin/fibrate treatments or other lipid-lowering medications
* Prior surgical procedure for weight control or current weight loss medication

Primary outcomes:
measure: Dyslipidemia Measures
timeFrame: Baseline
measure: Dyslipidemia Measures
timeFrame: Baseline to 8 weeks
measure: Dyslipidemia Measures
timeFrame: Baseline
measure: Dyslipidemia Measures
timeFrame: Baseline to 8 weeks
measure: Dyslipidemia Measures
timeFrame: Baseline
measure: Dyslipidemia Measures
timeFrame: Baseline to 8 weeks
measure: Dyslipidemia Measures
timeFrame: Baseline
measure: Dyslipidemia Measures
timeFrame: Baseline to 8 weeks
measure: Dyslipidemia Measures
timeFrame: Baseline
measure: Dyslipidemia Measures
timeFrame: Baseline to 8 weeks
measure: Dyslipidemia Measures
timeFrame: Baseline
measure: Dyslipidemia Measures
timeFrame: Baseline to 8 weeks
measure: Dyslipidemia Measures
timeFrame: Baseline
measure: Dyslipidemia Measures
timeFrame: Baseline to 8 weeks
measure: Insulin Resistance Indices
timeFrame: Baseline to 8 weeks
Secondary outcomes:
measure: Insulin Resistance Indices
timeFrame: Baseline
measure: Body Composition
timeFrame: Baseline
measure: Body Composition
timeFrame: Baseline to 8 weeks
measure: Surrogate Markers of Vascular Endothelial Function
timeFrame: Baseline
measure: Surrogate Markers of Vascular Endothelial Function
timeFrame: Baseline to 8 weeks
measure: Surrogate Markers of Vascular Endothelial Function as Measured by Augmentation Index
timeFrame: Baseline
measure: Surrogate Markers of Vascular Endothelial Function as Measured by Augmentation Index
timeFrame: Baseline to 8 weeks
Other outcomes:
Locations:
city: Birmingham
country: United States
facility: Bhuvana Sunil
state: Alabama
city: Birmingham
country: United States
facility: University of Alabama at Birmingham
state: Alabama
Study officials:
affiliation: University of Alabama at Birmingham
name: Bhuvana Sunil, MD
role: PRINCIPAL_INVESTIGATOR
References: