ABC Program in Patients With Metabolic Syndrome

This study has been completed.
Sponsor:
Information provided by:
University of Magdeburg
ClinicalTrials.gov Identifier:
NCT01417871
First received: August 15, 2011
Last updated: NA
Last verified: February 2010
History: No changes posted
  Purpose

Aims: We evaluate the efficacy of the "Active Body Control (ABC) Program" for weight reduction in patients with metabolic syndrome.

Methods: The ABC program combines telemonitoring of the physical activity with a low-calorie diet also preferring carbohydrates with low glycemic indexes. In this 12-month, randomized, clinical trial 60 patients will be treated according to the ABC program and 60 control patients will receive standard therapy.


Condition
Weight Reduction in Patients With Metabolic Syndrome

Study Type: Observational
Study Design: Observational Model: Case Control
Time Perspective: Prospective

Resource links provided by NLM:


Further study details as provided by University of Magdeburg:

Primary Outcome Measures:
  • weight reduction [ Time Frame: 12 month ] [ Designated as safety issue: Yes ]

Secondary Outcome Measures:
  • incidence of metabolic syndrome [ Time Frame: 12 month ] [ Designated as safety issue: Yes ]

Biospecimen Retention:   Samples Without DNA

blood samples for parameter of lipid metabolism


Enrollment: 140
Study Start Date: February 2010
Study Completion Date: August 2011
Primary Completion Date: August 2011 (Final data collection date for primary outcome measure)
Groups/Cohorts
case goup
Lifestyle counseling, ABC program
control group
usual care

  Eligibility

Ages Eligible for Study:   25 Years to 75 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Sampling Method:   Probability Sample
Study Population

patients with metabolic syndrome

Criteria

Inclusion Criteria:

  • metabolic syndrome

Exclusion Criteria:

  • tumor cachexia
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01417871

Locations
Germany
University Magdeburg
Magdeburg, Germany, 39120
Sponsors and Collaborators
University of Magdeburg
  More Information

No publications provided

Responsible Party: Claus Luley, University Magdeburg
ClinicalTrials.gov Identifier: NCT01417871     History of Changes
Other Study ID Numbers: abcmetsyn1
Study First Received: August 15, 2011
Last Updated: August 15, 2011
Health Authority: Germany: Federal Institute for Drugs and Medical Devices

Additional relevant MeSH terms:
Weight Loss
Metabolic Syndrome X
Body Weight Changes
Body Weight
Signs and Symptoms
Insulin Resistance
Hyperinsulinism
Glucose Metabolism Disorders
Metabolic Diseases

ClinicalTrials.gov processed this record on April 16, 2014