N/A N=30 Randomized Treatment

Effect of Low Carbohydrate Versus Low Fat Diet in the Treatment of Dyslipidemia in Obese Children With Metabolic Syndrome

Metabolic Syndrome · Obesity · Dyslipidemias

Bottom Line

View on ClinicalTrials.gov: NCT03937960 ↗

Enrolled (actual)

Serious AEs

0.0%

Results posted

Dec 2022

Primary outcome: Primary: Dyslipidemia Measures — 30; 32 mg/dL

Study Design & Population

Study type: Interventional
Phase: N/A
Interventions: Carbohydrate restricted group (Other); Standard low fat diet (Other)
Age: Pediatric, Adult · 10+ yrs
Sex: All
Sponsor: University of Alabama at Birmingham
Primary completion: Feb 2021

Outcome Measures

Outcome	Result	p-value
PRIMARY Dyslipidemia Measures	1.65; 1.68	—
PRIMARY Dyslipidemia Measures	1.65; 1.68	—
PRIMARY Dyslipidemia Measures	1.65; 1.68	—
PRIMARY Dyslipidemia Measures	1.65; 1.68	—
PRIMARY Dyslipidemia Measures	1.65; 1.68	—
PRIMARY Dyslipidemia Measures	1.65; 1.68	—
PRIMARY Dyslipidemia Measures	1.65; 1.68	—
PRIMARY Dyslipidemia Measures	1.65; 1.68	—
PRIMARY Dyslipidemia Measures	1.65; 1.68	—
PRIMARY Dyslipidemia Measures	1.65; 1.68	—
PRIMARY Dyslipidemia Measures	1.65; 1.68	—
PRIMARY Dyslipidemia Measures	1.65; 1.68	—
PRIMARY Dyslipidemia Measures	1.65; 1.68	—
PRIMARY Dyslipidemia Measures	1.65; 1.68	—
PRIMARY Insulin Resistance Indices	2.15; 2.21	—
SECONDARY Insulin Resistance Indices	2.15; 2.21	—
SECONDARY Body Composition	-8.7; -8.84	—
SECONDARY Body Composition	-8.7; -8.84	—
SECONDARY Surrogate Markers of Vascular Endothelial Function	-2; -2	—
SECONDARY Surrogate Markers of Vascular Endothelial Function	-2; -2	—
SECONDARY Surrogate Markers of Vascular Endothelial Function as Measured by Augmentation Index	-27; -28.6	—
SECONDARY Surrogate Markers of Vascular Endothelial Function as Measured by Augmentation Index	-27; -28.6	—

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.

Eligibility Criteria

Inclusion Criteria: 3 out of 5 of the following criteria

Metabolic syndrome with dyslipidemia
(HDL 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

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Data sourced from ClinicalTrials.gov (NCT03937960). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.