Clinical trial NCT01995149: Effect of Weight Loss on Cholesterol Metabolism in Hereditary Hypercholesterolemias and Overweight or Obesity.
Official title: Effect of Weight Loss on Lipids Concentration and Cholesterol Metabolism in Overweight and Obese Subjects With Primary Hypercholesterolemia.
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Familial Hypercholesterolemias
Weight Loss
Familial Combined Hypercholesterolemia
Obesity
Keywords: Familial Hypercholesterolemia
Familial Combined Hypercholesterolemia
Weight loss; Lipids; Phytosterols
Obesity
Overweight.
Lipids
Lead sponsor: Instituto Aragones de Ciencias de la Salud
Sponsor class: OTHER_GOV
Collaborators: name: Hospital Clinic of Barcelona
name: Instituto de Salud Carlos III
First posted: 2013-11-26
Enrollment: 78
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

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.


Eligibility criteria: 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.

Primary outcomes:
measure: Change in lipids and non-cholesterol sterols concentration
timeFrame: After 6 months of intervention
Secondary outcomes:
Other outcomes:
Locations:
Study officials:
affiliation: Unidad de Lípidos/Laboratorio de Investigación Molecular; Hospital Universitario Miguel Servet; Instituto Aragonés de Ciencias de la Salud
name: Fernando Civeira, MD, PhD
role: PRINCIPAL_INVESTIGATOR
References:
citation: Mateo-Gallego R, Perez-Calahorra S, Cofan M, Baila-Rueda L, Cenarro A, Ros E, Puzo J, Civeira F. Serum lipid responses to weight loss differ between overweight adults with familial hypercholesterolemia and those with familial combined hyperlipidemia. J Nutr. 2014 Aug;144(8):1219-26. doi: 10.3945/jn.114.191775. Epub 2014 Jun 4.