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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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

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

ClinicalTrials.gov processed this record on November 20, 2014