NCT01145092

Brief Summary

Life style intervention including diet and exercise is the recommended strategy for prevention of type 2 diabetes mellitus (T2DM). First-degree relatives of patients with type 2 diabetes mellitus have an increased risk of insulin resistance and a lifetime risk of developing type 2 diabetes of 40%- 80%. Poor physical fitness is a strong indicator of an increased risk of developing diabetes. Long-term endurance exercise training has been shown to increase insulin sensitivity in sedentary young and elderly individuals, first degree relatives of patients with Type 2 diabetes, glucose intolerant obese, or Type 2 diabetic humans. In type 2 diabetic patients, non-diabetic individuals with IGT and sedentary adults after exercise training of different intensity, different duration and different frequency an increase of insulin sensitivity was found. However, despite the vast knowledge concerning beneficial effects physical activity for the prevention of T2DM (and many other chronic metabolic disorders) to date wide ranging strategies have not been realized satisfactory. Regardless of age, ethnicity, sex or health status the lack of time is the primary reason for the failure to exercise on a regular basis (or is stated as primary reason). Therefore the investigators aimed at investigating whether a controlled endurance/resistance training twice a week over 6 month might be beneficial for healthy, non obese, first degree relatives with T2DM. Therefore the investigators measure parameters associated with the prevention of T2DM like insulin sensitivity, flux through fATPase and fCK, intramyocellular and hepatocellular lipids.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
16

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
3.1 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

March 1, 2009

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

March 1, 2009

Completed
1.3 years until next milestone

First Submitted

Initial submission to the registry

June 14, 2010

Completed
2 days until next milestone

First Posted

Study publicly available on registry

June 16, 2010

Completed
Last Updated

June 16, 2010

Status Verified

June 1, 2010

Enrollment Period

3.1 years

First QC Date

June 14, 2010

Last Update Submit

June 15, 2010

Conditions

Keywords

type 2 diabetesexercise trainingATP-synthesisintramyocellular lipidshepatocellular lipidsfirst degree relatives of T2DM patients

Outcome Measures

Primary Outcomes (1)

  • Insulin Sensitivity

    measured by oral glucose tolerance test

Secondary Outcomes (4)

  • incremental test power, oxygen uptake (VO2 in ml.kg-1.min-1), "aerobic threshold" (RCP= respiratory compensation point)

  • ATP-Synthesis

  • liver lipid content

  • skeletal muscle lipid content

Interventions

The endurance training group exercised on a cycle ergometer (90% of power output determined at the respiratory compensation point = RCP). The duration of each training unit was increased with time. The resistance group trained on 8 weight machines where the workload gradually increased every 2-3 weeks. At week 13 an additional physical examination, OGTT and spiro-ergometry for adjusting the training were performed.

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 2Insulin Resistance

Interventions

ExerciseEndurance Training

Condition Hierarchy (Ancestors)

Diabetes MellitusGlucose Metabolism DisordersMetabolic DiseasesNutritional and Metabolic DiseasesEndocrine System DiseasesHyperinsulinism

Intervention Hierarchy (Ancestors)

Motor ActivityMovementMusculoskeletal Physiological PhenomenaMusculoskeletal and Neural Physiological PhenomenaExercise TherapyRehabilitationAftercareContinuity of Patient CarePatient CareTherapeuticsPhysical Therapy ModalitiesPhysical Conditioning, Human

Study Officials

  • Michael Roden, Prof.

    Institute for Clinical Diabetology, German Diabetes Center (Leibniz Center for Diabetes Research), Department of Metabolic Diseases, Heinrich-Heine University and University Clinics Düsseldorf, Germany

    STUDY DIRECTOR

Study Design

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

Study Record Dates

First Submitted

June 14, 2010

First Posted

June 16, 2010

Study Start

February 1, 2006

Primary Completion

March 1, 2009

Study Completion

March 1, 2009

Last Updated

June 16, 2010

Record last verified: 2010-06

Locations