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

This study has been completed.
Sponsor:
Collaborators:
Hospital Clinic of Barcelona
Instituto de Salud Carlos III
Information provided by (Responsible Party):
Fernando Civeira, Instituto Aragones de Ciencias de la Salud
ClinicalTrials.gov Identifier:
NCT01995149
First received: November 21, 2013
Last updated: November 25, 2013
Last verified: November 2013
  Purpose

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.


Condition Intervention
Familial Hypercholesterolemias
Weight Loss
Familial Combined Hypercholesterolemia
Obesity
Behavioral: Weight loss and dietary intervention

Study Type: Interventional
Study Design: Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: Effect of Weight Loss on Lipids Concentration and Cholesterol Metabolism in Overweight and Obese Subjects With Primary Hypercholesterolemia.

Resource links provided by NLM:


Further study details as provided by Instituto Aragones de Ciencias de la Salud:

Primary Outcome Measures:
  • Change in lipids and non-cholesterol sterols concentration [ Time Frame: After 6 months of intervention ] [ Designated as safety issue: No ]

    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).


Enrollment: 78
Study Start Date: June 2010
Primary Completion Date: September 2012 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Weight loss and dietary intervention
The weight loss intervention had a total duration of 6 months. Each participant's caloric prescription represented a deficit of 600 kcal per day as calculated from the person's resting energy expenditure and activity level using the Harris-Benedict equation. In general, prescribed energy intake was between 1200 kcal and 1600 kcal/day. Dietary composition consisted on 50-55% of carbohydrates, 15-20% of protein and 30% of fat and included a wide variety of foods typical of a Mediterranean diet. Patients were also provided with recipes and shopping counselling to improve intervention compliance and to achieve the weight loss goal. Individual consultations with a nutritionist were performed twice a month to motivate the weight loss and reinforce the intervention.
Behavioral: Weight loss and dietary intervention
The weight loss intervention had a total duration of 6 months. Each participant's caloric prescription represented a deficit of 600 kcal per day as calculated from the person's resting energy expenditure and activity level using the Harris-Benedict equation. In general, prescribed energy intake was between 1200 kcal and 1600 kcal/day. Dietary composition consisted on 50-55% of carbohydrates, 15-20% of protein and 30% of fat and included a wide variety of foods typical of a Mediterranean diet. Patients were also provided with recipes and shopping counselling to improve intervention compliance and to achieve the weight loss goal. Individual consultations with a nutritionist were performed twice a month to motivate the weight loss and reinforce the intervention.

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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.
  Contacts and Locations
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Please refer to this study by its ClinicalTrials.gov identifier: NCT01995149

Sponsors and Collaborators
Instituto Aragones de Ciencias de la Salud
Hospital Clinic of Barcelona
Instituto de Salud Carlos III
Investigators
Principal Investigator: Fernando Civeira, MD, PhD Unidad de Lípidos/Laboratorio de Investigación Molecular; Hospital Universitario Miguel Servet; Instituto Aragonés de Ciencias de la Salud
  More Information

No publications provided by Instituto Aragones de Ciencias de la Salud

Additional publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Responsible Party: Fernando Civeira, Professor, Instituto Aragones de Ciencias de la Salud
ClinicalTrials.gov Identifier: NCT01995149     History of Changes
Other Study ID Numbers: I+CS;CEICA-B80, I+CS-HUMS-B80
Study First Received: November 21, 2013
Last Updated: November 25, 2013
Health Authority: Spain: Comité Ético de Investigación Clínica

Keywords provided by Instituto Aragones de Ciencias de la Salud:
Familial Hypercholesterolemia
Familial Combined Hypercholesterolemia
Weight loss; Lipids; Phytosterols
Obesity
Overweight.
Lipids

Additional relevant MeSH terms:
Hypercholesterolemia
Obesity
Body Weight
Overweight
Weight Loss
Hyperlipoproteinemia Type II
Overnutrition
Nutrition Disorders
Signs and Symptoms
Body Weight Changes
Hyperlipidemias
Dyslipidemias
Lipid Metabolism Disorders
Metabolic Diseases
Lipid Metabolism, Inborn Errors
Metabolism, Inborn Errors
Genetic Diseases, Inborn
Hyperlipoproteinemias

ClinicalTrials.gov processed this record on September 30, 2014