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The Effect of Acute and Chronic Exercise at the Metabolic Syndrome and Markers of Inflammation in Obese Subjects

Primary Purpose

Obesity, Healthy

Status

Unknown status

Phase

Not Applicable

Locations

Denmark

Study Type

Interventional

Intervention

Exercise-only (EXO-12 weeks of regular supervised exercise without diet restriction)

Diet-only (DIO-8 weeks of very low energy diet (VLED 600 kcal/d) followed by 4 weeks weight maintenance diet

Diet+exercise (DEX-8 weeks VLED 800 kcal/d + a four weeks weight maintenance diet combined with regular supervised exercise throughout the 12 weeks).

About this trial

This is an interventional treatment trial for Obesity focused on measuring Obese, Adults

Eligibility Criteria

18 Years - 45 Years (Adult)All SexesAccepts Healthy Volunteers

Inclusion Criteria:

Age 18-45 years,
obese (30 kg/m2 < BMI < 40 kg/m2) physically inactive (<30 minutes pr. day)
and weight stabile for at least three months (± 2 kg of current body weight)

Exclusion Criteria:

cardiovascular disease,
type 2 diabetes, pregnancy or orthopaedic difficulties causing inability to undertake an exercise program

Sites / Locations

Department of Medicine and Endocrinology CRecruiting

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm Type

Active Comparator

Arm Label

EXO

DIO

DEX

Arm Description

Exercise-only (EXO-12 weeks of regular supervised exercise without diet restriction),

Diet-only (DIO-8 weeks of very low energy diet (VLED 600 kcal/d) followed by 4 weeks weight maintenance diet)

Diet+exercise (DEX-8 weeks VLED 800 kcal/d + a four weeks weight maintenance diet combined with regular supervised exercise throughout the 12 weeks).

Outcomes

Primary Outcome Measures

Changes in inflammatory markers as Adiponectin, MCP-1, Interleukin-6 and CRP. Moreover changes in body composition quantified with MRI

Change in Interleukin-6 and other inflammatory markers in plasma, adipose tissue and muscle tissue

Secondary Outcome Measures

Full Information

NCT ID

NCT00700245

First Posted

June 17, 2008

Last Updated

June 17, 2008

Sponsor

Aarhus University Hospital

1. Study Identification

Unique Protocol Identification Number

NCT00700245

Brief Title

The Effect of Acute and Chronic Exercise at the Metabolic Syndrome and Markers of Inflammation in Obese Subjects

Official Title

The Effect of Acute and Chronic Exercise at the Metabolic Syndrome and Markers of Inflammation in Obese Subjects

Study Type

Interventional

2. Study Status

Record Verification Date

June 2008

Overall Recruitment Status

Unknown status

Study Start Date

September 2006 (undefined)

Primary Completion Date

June 2008 (Anticipated)

Study Completion Date

March 2009 (Anticipated)

3. Sponsor/Collaborators

Name of the Sponsor

Aarhus University Hospital

4. Oversight

Data Monitoring Committee

5. Study Description

Brief Summary

The human adipose and muscle -tissue produce and release a number of bioactive proteins which contributes to the chronic low grade of inflammatory status which is associated with obesity and plays an important role in the pathogenesis of type 2 diabetes and cardiovascular diseases. Study 1: Our aim is to investigate if exercise has independent and additive effects in combination with diet-induced weight loss on circulating levels of inflammatory markers and mRNA levels in subcutaneous adipose tissue (SAT) and skeletal muscle tissue (SM. Study 2: Our aim is to investigate whether gender and weight status plays a role in the metabolic response during two hours of acute exercise

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Obesity, Healthy

Keywords

Obese, Adults

7. Study Design

Primary Purpose

Treatment

Study Phase

Not Applicable

Interventional Study Model

Parallel Assignment

Masking

None (Open Label)

Allocation

Randomized

Enrollment

100 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title

EXO

Arm Type

Active Comparator

Arm Description

Exercise-only (EXO-12 weeks of regular supervised exercise without diet restriction),

Arm Title

DIO

Arm Type

Active Comparator

Arm Description

Diet-only (DIO-8 weeks of very low energy diet (VLED 600 kcal/d) followed by 4 weeks weight maintenance diet)

Arm Title

DEX

Arm Type

Active Comparator

Arm Description

Diet+exercise (DEX-8 weeks VLED 800 kcal/d + a four weeks weight maintenance diet combined with regular supervised exercise throughout the 12 weeks).

Intervention Type

Behavioral

Intervention Name(s)

Exercise-only (EXO-12 weeks of regular supervised exercise without diet restriction)

Intervention Description

The exercise intervention for subjects in the EXO consisted of supervised aerobic exercise three times per week with a duration of 60 -75 minutes pr. training session, with an estimated energy expenditure of 500-600 kcal per session. The subjects could choose between different modes of exercise; stationary bicycling, jogging on a treadmill or stair stepping.

Intervention Type

Behavioral

Intervention Name(s)

Diet-only (DIO-8 weeks of very low energy diet (VLED 600 kcal/d) followed by 4 weeks weight maintenance diet

Intervention Description

Subjects in the DIO group were prescribed a liquid VLED(Nupo, Copenhagen) of respectively 600 and 800 kcal pr. day (proteins 41 g, carbohydrates 29 g, fat 5.6 g. pr 100 gram) for eight weeks followed by a weight maintenance diet for four weeks.

Intervention Type

Behavioral

Intervention Name(s)

Diet+exercise (DEX-8 weeks VLED 800 kcal/d + a four weeks weight maintenance diet combined with regular supervised exercise throughout the 12 weeks).

Intervention Description

The exercise intervention for subjects in the DEX group consisted of supervised aerobic exercise three times per week with a duration of 60 -75 minutes pr. training session, with an estimated energy expenditure of 500-600 kcal per session

Primary Outcome Measure Information:

Title

Changes in inflammatory markers as Adiponectin, MCP-1, Interleukin-6 and CRP. Moreover changes in body composition quantified with MRI

Time Frame

8 weeks and 12 weeks

Title

Change in Interleukin-6 and other inflammatory markers in plasma, adipose tissue and muscle tissue

Time Frame

60, 120 240 minutes

10. Eligibility

Sex

All

Minimum Age & Unit of Time

18 Years

Maximum Age & Unit of Time

45 Years

Accepts Healthy Volunteers

Eligibility Criteria

Inclusion Criteria: Age 18-45 years, obese (30 kg/m2 < BMI < 40 kg/m2) physically inactive (<30 minutes pr. day) and weight stabile for at least three months (± 2 kg of current body weight) Exclusion Criteria: cardiovascular disease, type 2 diabetes, pregnancy or orthopaedic difficulties causing inability to undertake an exercise program

Central Contact Person:

First Name & Middle Initial & Last Name or Official Title & Degree

Tore SB Christiansen, Master of health science

Phone

004589497737

tore.christiansen@ki.au.dk

First Name & Middle Initial & Last Name or Official Title & Degree

Søren K Paulsen, MD

Phone

004589497736

skpaulsen@ki.au.dk

Facility Information:

Facility Name

Department of Medicine and Endocrinology C

City

Aarhus

ZIP/Postal Code

8000

Country

Denmark

Individual Site Status

Recruiting

Facility Contact:

First Name & Middle Initial & Last Name & Degree

Bjørn Richelsen, Professor dr.med

Phone

004589497696

brich@dadlnet.dk

First Name & Middle Initial & Last Name & Degree

Tore Christiansen, M. Health S.

12. IPD Sharing Statement

Learn more about this trial

The Effect of Acute and Chronic Exercise at the Metabolic Syndrome and Markers of Inflammation in Obese Subjects

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