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ABC Program in Patients With Metabolic Syndrome

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT01417871
First Posted: August 16, 2011
Last Update Posted: August 16, 2011
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Information provided by:
University of Magdeburg
  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 ]

Secondary Outcome Measures:
  • incidence of metabolic syndrome [ Time Frame: 12 month ]

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

Information from the National Library of Medicine

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Ages Eligible for Study:   25 Years to 75 Years   (Adult, Senior)
Sexes Eligible for Study:   All
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
Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01417871


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

Responsible Party: Claus Luley, University Magdeburg
ClinicalTrials.gov Identifier: NCT01417871     History of Changes
Other Study ID Numbers: abcmetsyn1
First Submitted: August 15, 2011
First Posted: August 16, 2011
Last Update Posted: August 16, 2011
Last Verified: February 2010

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