Effect of Weight Loss on Cholesterol Metabolism in Hereditary Hypercholesterolemias and Overweight or Obesity.

Not Applicable

Completed

• Conditions: Familial Hypercholesterolemias; Weight Loss; Familial Combined Hypercholesterolemia; Obesity

• Registration Number: NCT01995149
• Lead Sponsor: Instituto Aragones de Ciencias de la Salud

Brief Summary

Background: Lipid lowering response to weight loss in subjects with genetic hyperlipidemias and overweight or obesity and its effect on cholesterol metabolism has not been studied.

Objective: To explore the effects of weight loss on lipid values and cholesterol metabolism, by measuring circulating non-cholesterol sterols, in overweight or obese subjects with genetic hypercholesterolemias.

Design: The investigators conducted a 6-months weight loss intervention in subjects with the diagnosis of familial hypercholesterolemia (FH) or familial combined hyperlipidemia (FCHL), body mass index \>25 kg/m2, steady weight (±3 kg in the last 3 months) and absence of lipid lowering drugs in the previous 5 weeks. They were advised to follow a hypocaloric diet with a deficit of 600 kcal (30% fat, 15% protein, and 55% carbohydrates) per day as calculated from the person's resting energy expenditure and activity level. Anthropometric data, biochemical analysis including lipids, apolipoproteins and non-cholesterol sterols were evaluated at baseline, 3 months and 6 months.

Detailed Description

Not available

Study Timeline

• Study Start: 2010-06
• Primary Completion: 2012-09
• Status Verified: 2013-11
• Study First Submitted: 2013-11-21
• Study First Submitted QC: 2013-11-25
• Last Update Submitted: 2013-11-25
• Study First Posted: 2013-11-26
• Last Update Posted: 2013-11-26

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 78

Inclusion Criteria

• Age ≥18 years.

• Diagnosis of Familial Combined Hyperlipidemia* and Familial Hypercholesterolemia**.

• Body mass index > 25 kg/m2.

• Steady weight (±3 kg in the last 3 months).

• Absence of lipid lowering drugs including sterols supplements in the previous 5 weeks.

  • Familial Combined Hyperlipidemia diagnosis was based on the presence of primary combined hyperlipidaemia in untreated patients whose serum cholesterol and triglyceride concentrations were above the sex- and age-specific 90th percentiles for the Spanish population, serum total apolipoprotein B concentration ≥ 120 mg/dL and there was at least one first-degree relative with hyperlipidemia (total cholesterol and/or triglycerides >90th percentile) (Gómez-Gerique JA et al; 1999).

    • Familial Hypercholesterolemia was diagnosed in subjects with off-treatment LDL cholesterol concentrations above the age- and sex-specific 95th percentile of a Spanish reference population, triglyceride below 200 mg/dL and familial vertical transmission with at least one first-degree relative with LDL cholesterol above age- and sex-specific 95th percentiles (Gómez-Gerique JA et al; 1999).

Exclusion Criteria

• Alcohol consumption >30 gr/day.
• Uncontrolled type-2 diabetes (HbA1c >8%).
• Any other disease that could interfere with the ability to comply with the study protocol were excluded
• Personal history of cardiovascular disease, very high risk as defined by the presence of ≥ 2 major risk factors, or total cholesterol ≥ 350 mg/dL since lipid-lowering drug were considered highly recommended.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Primary Outcome Measures

Name	Time	Method
Change in lipids and non-cholesterol sterols concentration	After 6 months of intervention	Main outcome it the variation of: * Lipids: Total cholesterol, LDL cholesterol, HDL cholesterol, tryglicerides and apolipoprotein B.; * Non-cholesterol sterols: Phytosterols (campesterol, stigmasterol and sitosterols) and cholestanol (which are stated as subrogate markers of intestinal cholesterol absorption) and desmosterol, lathosterol and lanosterol (cholesterol synthesis markers).