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

Obesity Clinical Trial

Official title:

Effect of Weight Loss on Lipids Concentration and Cholesterol Metabolism in Overweight and Obese Subjects With Primary Hypercholesterolemia.

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01995149
• Other study ID #: I+CS;CEICA-B80
• Secondary ID: I+CS-HUMS-B80
• Status: Completed
• Phase: N/A
• First received: November 21, 2013
• Last updated: November 25, 2013
• Start date: June 2010

Study information

• Verified date: November 2013
• Source: Instituto Aragones de Ciencias de la Salud
• Contact: n/a
• Is FDA regulated: No
• Health authority: Spain: Comité Ético de Investigación Clínica
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 78
• Est. primary completion date: September 2012
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

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

Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Body Weight
• Familial Combined Hypercholesterolemia
• Familial Hypercholesterolemias
• Hypercholesterolemia
• Hyperlipoproteinemia Type II
• Obesity
• Overweight
• Weight Loss

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.

Locations

Country	Name	City	State
n/a

Sponsors (3)

Lead Sponsor	Collaborator
Instituto Aragones de Ciencias de la Salud	Hospital Clinic of Barcelona, Instituto de Salud Carlos III

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Change in lipids and non-cholesterol sterols concentration	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).	After 6 months of intervention	No