NCT01649219

Brief Summary

Our aim is to investigate the effects of a 12-week structured aerobic exercise on fasting and 2 h glucose, insulin and lipid concentrations in sedentary overweight subjects in whom impaired fasting glucose and/or impaired glucose tolerance was observed for the first time.

Trial Health

43
At Risk

Trial Health Score

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

Trial has exceeded expected completion date
Enrollment
80

participants targeted

Target at P25-P50 for phase_4

Timeline
Completed

Started Jan 2010

Longer than P75 for phase_4

Geographic Reach
1 country

1 active site

Status
unknown

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

January 1, 2010

Completed
5 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 1, 2010

Completed
2.1 years until next milestone

First Submitted

Initial submission to the registry

July 21, 2012

Completed
4 days until next milestone

First Posted

Study publicly available on registry

July 25, 2012

Completed
10 months until next milestone

Study Completion

Last participant's last visit for all outcomes

June 1, 2013

Completed
Last Updated

July 25, 2012

Status Verified

July 1, 2012

Enrollment Period

5 months

First QC Date

July 21, 2012

Last Update Submit

July 24, 2012

Conditions

Prediabetes

Keywords

Prediabetes, objectively measured exercise, glucose and lipid metabolism, dose response, muscle metabolism.

Outcome Measures

Primary Outcomes (1)

  • Glucose and lipid metabolism

    3-month intervention

Secondary Outcomes (1)

  • Changes in muscle metabolism

    3-months intervention

Study Arms (2)

Exercise intervention

EXPERIMENTAL

3-month supervised exercise intervention 3 times per week; 60min per time.

Behavioral: Exercise

No intervention

NO INTERVENTION

Standard couselling at baseline

Interventions

ExerciseBEHAVIORAL
Exercise intervention

Eligibility Criteria

Age30 Years - 70 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • prediabetes determined by 2 hr oGTT

You may not qualify if:

  • any functional limitation or chronic disease that might have limited the physical exercise and testing
  • vigorous physical activity/exercise as revealed by questionnaire and physician exam

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

University of Oulu

Oulu, 90014, Finland

Location

MeSH Terms

Conditions

Prediabetic State

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

  • Karl-Heinz Herzig, MD,PhD

    University of Oulu

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
phase 4
Allocation
RANDOMIZED
Masking
NONE
Purpose
PREVENTION
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

July 21, 2012

First Posted

July 25, 2012

Study Start

January 1, 2010

Primary Completion

June 1, 2010

Study Completion

June 1, 2013

Last Updated

July 25, 2012

Record last verified: 2012-07

Locations

FI(1)