N/A
Completed N=30
Effect of Low Carbohydrate Versus Low Fat Diet in the Treatment of Dyslipidemia in Obese Children With Metabolic Syndrome
Metabolic Syndrome · Obesity · Dyslipidemias
Source: ClinicalTrials.gov NCT03937960 ↗
Enrolled (actual)
30
Serious AEs
0.0%
Results posted
Dec 2022
Primary outcomePrimary: Dyslipidemia Measures — 30; 32 mg/dL
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.
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| 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 Surrogate Markers of Vascular Endothelial Function |
-2; -2 | — |
| SECONDARY Surrogate Markers of Vascular Endothelial Function as Measured by Augmentation Index |
-27; -28.6 | — |
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
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. Informational only — not medical advice.