ABC Program in Patients With Metabolic Syndrome | NCT01417871

Studies
ABC Program in Patients With Metabolic Syndrome

NCT01417871

Sponsor

University of Magdeburg

Status

Completed

Last Update Posted

Aug 16, 2011Estimated

Enrollment

140Actual

Phase

Not provided

Conditions

Weight Reduction in Patients With Metabolic Syndrome

Interventions

Not provided

Countries

Germany

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Feb 2010

Overall Recruitment Status or Expanded Access Status

Completed

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Feb 2010

Primary Completion Date

Aug 2011Actual

Completion Date

Aug 2011Actual

First Submitted Date

Aug 15, 2011

First Submission Date that Met QC Criteria

Aug 15, 2011

First Posted Date

Aug 16, 2011Estimated

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Aug 15, 2011

Last Update Posted Date

Aug 16, 2011Estimated

Oversight Module

Has Data Monitoring Committee (DMC)

Is FDA Regulated Drug

Not provided

Is FDA Regulated Device

Not provided

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

Brief Summary

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.

Detailed Description

Not provided

Design Module

Study Type

Observational

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Not provided

Target Follow-Up Duration

Not provided

Phases

Not provided

Interventional Study Design

Allocation

Not provided

Intervention Model

Biospecimen

Retention

Enrollment

140Actual

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
case goup		Lifestyle counseling, ABC program
control group		usual care

Interventions

Not provided

Measure	Description	Time Frame
weight reduction		12 month

Measure	Description	Time Frame
incidence of metabolic syndrome		12 month

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

metabolic syndrome

Exclusion Criteria:

tumor cachexia

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

25 Years

Maximum Age

75 Years

Standard Ages

AdultOlder Adult

Study Population

patients with metabolic syndrome

Sampling Method

Probability Sample

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

Not provided

Locations

Facility	Status	City	State	ZIP	Country	Contacts
University Magdeburg		Magdeburg		39120	Germany