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NCT Number: NCT00626964

Prevention of Coronary Heart Disease in Morbidly Obese Patients

The changes in risks of developing coronary heart disease in patients with morbid obesity after different weight loss interventions have not been extensively studied. The primary objective of this study is to investigate whether an intensive lifestyle intervention program in a tertiary care clinic (Spesialsykehuset for Rehabilitering) is comparable with a 7-week low-energy-diet followed by bariatric surgery in decreasing the risk of cardiovascular disease in these patients.

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This study is active but is not currently recruiting participants.

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Key information

Conditions

Morbid Obesity Apnea Arthritis Body Weight Cardiovascular Diseases Dyssomnias Hypertension Joint Diseases Musculoskeletal Diseases Nervous System Diseases Nutrition Disorders Nutritional and Metabolic Diseases Obesity Obesity, Morbid Obstructive Sleep Apnea Osteoarthritis Osteoarthrosis Overnutrition Overweight Pathological Conditions, Signs and Symptoms Respiration Disorders Respiratory Tract Diseases Rheumatic Diseases Signs and Symptoms Sleep Apnea Syndromes Sleep Apnea, Obstructive Sleep Disorders, Intrinsic Sleep Wake Disorders Type 2 DM Vascular Diseases

Age range

18 year–70 year

Sex eligibility

All sexes

Study type

Observational

Primary location

Morbid Obesity Center, Vestfold Hospital Trust

Tønsberg, 3115, Norway

About this study

Patients matching the eligibility criteria were divided into two groups (not randomized). One group underwent a 7 weeks Low-Energy-Diet before bariatric surgery, the other group participated in an intensive lifestyle intervention program for 3 months.

Data on arterial stiffness, body weight, body composition, blood pressure, blood samples, vital parameters are registered in the both groups at baseline, 7 weeks and after 1 year.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • Morbidly Obese patients with BMI > 40, or BMI > 35 with comorbidity such as Hypertension, Obstructive Sleep Apnea, Weight Related Osteoarthrosis, Type 2 DM.

Exclusion criteria

  • Participation in other weight loss program the last 12 months. Serious psychiatric conditions

Treatment and study plan

bariatric surgery

Procedure

Bariatric Surgery Treatment: Duodenal Switch, Gastric Sleeve or Gastric bypass.

Conservative Treatment:

Behavioral

Intensive Lifestyle Intervention Program

Other names: Conservative

Primary outcomes

  1. Arterial stiffness

    Time frame: 7 weeks and 1 year

    Pulse wave velocity and augmentation index

  2. Cardiovascular risk factors

    Time frame: 7 weeks and 1 year

    Several biomarkers will be examined

Sponsors and collaborators

Lead sponsor

The Hospital of Vestfold

Other

Collaborators

  • Oslo University Hospital

Registry information

Official study title

Prevention of Coronary Heart Disease in Morbidly Obese Patients. Lifestyle Intervention, Low Energy Diet or Bariatric Surgery.

Acronym: SphCor

Important dates

Study start
2008
Primary completion
2026
Study completion
2026
First posted
Feb 29, 2008
Registry last updated
Jun 11, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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