NCT00710008

Brief Summary

First degree relatives of type 2 diabetic patients (T2DM) suffer an increased risk of developing this disease themselves, starting with impaired insulin sensitivity. This risk can be minimized by lifestyle interventions such as regular exercise training. Until this day, little is known about the short-term effects of exercise training on insulin sensitivity and the lipid content of the liver and skeletal muscle.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
26

participants targeted

Target at below P25 for not_applicable type-2-diabetes-mellitus

Timeline
Completed

Started Feb 2006

Typical duration for not_applicable type-2-diabetes-mellitus

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

February 1, 2006

Completed
2.3 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 1, 2008

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

June 1, 2008

Completed
29 days until next milestone

First Submitted

Initial submission to the registry

June 30, 2008

Completed
3 days until next milestone

First Posted

Study publicly available on registry

July 3, 2008

Completed
Last Updated

August 20, 2008

Status Verified

July 1, 2008

Enrollment Period

2.3 years

First QC Date

June 30, 2008

Last Update Submit

August 19, 2008

Conditions

Type 2 Diabetes Mellitus

Keywords

type 2 diabetes,exercise training,ATP-synthesis,intramyocellular lipids,hepatocellular lipidsfirst degree relatives ofpatients

Outcome Measures

Primary Outcomes (1)

  • ATP-Synthesis, liver lipid content, skeletal muscle lipid content

Interventions

exercise trainingOTHER

3 bouts of exercise at 90%RCP during one week

Eligibility Criteria

Age18 Years - 70 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • First degree relatives of type 2 diabetic patients
  • Age: 18-50 years
  • BMI \<30 kg/m2 (due to limited MR diameter)
  • Normal routine lab tests (blood cell count, kidney, liver, pancreas, thyroid and neuromuscular function)
  • Availability within the local area throughout the study
  • Ability to understand and sign the consent forms

You may not qualify if:

  • Current smoking
  • Present drug treatment
  • Regular exercise training
  • Contraindications for MRS studies: claustrophobia and metalliferous implants
  • Pregnancy
  • HIV or Hepatitis
  • Acute disease 2 weeks previous to the examination
  • Heart disease
  • Hypertension (RR\>140/95)
  • Liver disease
  • Kidney disease
  • Pulmonary disease
  • Thyroid disease

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Landsteiner Institute

Vienna, Vienna, 1140, Austria

Location

MeSH Terms

Conditions

Diabetes Mellitus, Type 2

Interventions

Exercise

Condition Hierarchy (Ancestors)

Diabetes MellitusGlucose Metabolism DisordersMetabolic DiseasesNutritional and Metabolic DiseasesEndocrine System Diseases

Intervention Hierarchy (Ancestors)

Motor ActivityMovementMusculoskeletal Physiological PhenomenaMusculoskeletal and Neural Physiological Phenomena

Study Officials

  • Michael Roden, Prof.Dr.

    Landsteiner Institute

    STUDY DIRECTOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NON RANDOMIZED
Masking
NONE
Purpose
PREVENTION
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER

Study Record Dates

First Submitted

June 30, 2008

First Posted

July 3, 2008

Study Start

February 1, 2006

Primary Completion

June 1, 2008

Study Completion

June 1, 2008

Last Updated

August 20, 2008

Record last verified: 2008-07

Locations

AU(1)