NCT01377558

Brief Summary

The purposes of the study are

  • to determine which kind of supervised exercise intervention (aerobic endurance training versus strength endurance training versus combined aerobic endurance and strength endurance training) is more effective in improving the metabolic parameters in typ 2 diabetes patients
  • to investigate what kind of intervention is more successful in reduction of concomitant diseases and improving quality of life
  • to assess what kind of intervention induces highest effects in long term persistence of these positive changes

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
100

participants targeted

Target at P50-P75 for not_applicable type-2-diabetes

Timeline
Completed

Started Apr 2011

Geographic Reach
1 country

2 active sites

Status
unknown

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

Trial Relationships

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

April 1, 2011

Completed
2 months until next milestone

First Submitted

Initial submission to the registry

June 9, 2011

Completed
12 days until next milestone

First Posted

Study publicly available on registry

June 21, 2011

Completed
4 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

November 1, 2011

Completed
7 months until next milestone

Study Completion

Last participant's last visit for all outcomes

June 1, 2012

Completed
Last Updated

June 23, 2011

Status Verified

April 1, 2011

Enrollment Period

7 months

First QC Date

June 9, 2011

Last Update Submit

June 22, 2011

Conditions

Type 2 Diabetes

Keywords

aerobic trainingresistance trainingcombination of aerobic and resistance trainingdiabetestype 2 diabetesHbA1cendothelial dysfunctioninflammation markersParodontitisExercise interventiontraining

Outcome Measures

Primary Outcomes (1)

  • Change in HbA1c-level (haemoglobin A1c)

    6 months

Secondary Outcomes (29)

  • Change in HOMA-Index

    3 and 6 months

  • Change in beta-cell-function

    3 and 6 months

  • Change in fasting plasma glucose levels

    3 and 6 months

  • Change in total cholesterol levels

    3 and 6 months

  • Change in HDL-cholesterol levels

    3 and 6 months

  • +24 more secondary outcomes

Study Arms (4)

Aerobic endurance training intervention

EXPERIMENTAL

Aerobic endurance training

Other: Aerobic endurance training intervention

Strength endurance training intervention

EXPERIMENTAL

Strength endurance training

Other: Strength endurance training intervention

Combined training intervention

EXPERIMENTAL

Combined aerobic endurance training and strength endurance training intervention

Other: Combined aerobic endurance and strength endurance training

Control group

NO INTERVENTION

control group

Interventions

Aerobic endurance training interventionOTHER

The aerobic endurance training group will use cardiovascular training devices week 1-4: 15 minutes warm up (group) 15 minutes intervention at 80-100% vAT two times per week week 5-13: 15 minutes warm up (group) 30 minutes intervention at 95-110% vAT two times per week week 14-26: 15 minutes warm up (group) 45 minutes intervention at 95-110% vAT two times per week

Also known as: aerobic endurance training
Aerobic endurance training intervention
Strength endurance training interventionOTHER

The strength endurance training intervention group will perform eight exercises on weight machines (Milon circuit training- 60 seconds activity, 30 seconds break) week 1-4: 15 minutes warm up (group) 1 session resistance training intensity 3 (Buskies) two times per week week 5-13: 15 minutes warm up (group) 2 sessions resistance training intensity 5 (Buskies) two times per week week 14-26: 15 minutes warm up (group) 3 sessions resistance training intensity 5 (Buskies) two times per week

Also known as: Strength endurance training
Strength endurance training intervention
Combined aerobic endurance and strength endurance trainingOTHER

week 1-4: 15 minutes warm up (group) 15 minutes intervention at 80-100% vAT once per week and 15 minutes warm up (group) 1 session resistance training intensity 3 (Buskies) once per week week 5-13: 15 minutes warm up (group) 15 minutes intervention at 95-110% vAT and 1 session resistance training intensity 5 (Buskies) two times per week week 14-26: 15 minutes warm up (group) 30 minutes intervention at 95-110% vAT and 1 session resistance training intensity 5 (Buskies) once a week and 15 minutes warm up (group) 15 minutes intervention at 95-110% vAT and 2 sessions resistance training intensity 5 (Buskies) once a week

Combined training intervention

Eligibility Criteria

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

You may qualify if:

  • diagnoses of type 2 diabetes (ADA criteria)
  • admitted diabetes treatments will be diet and oral hypoglycemic agents

You may not qualify if:

  • sports intervention \>60 minutes per week
  • medical conditions
  • preproliferative or proliferative retinopathy
  • instable coronary heart disease
  • inability to perform the scheduled physical activity programs
  • acute clinically significant intercurrent diseases

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (2)

University of Giessen

Giessen, Hesse, 35394, Germany

Location

Sportpark Zwickau, Glauchau, Meerane

Zwickau, Saxony, 08056, Germany

Location

MeSH Terms

Conditions

Diabetes Mellitus, Type 2Diabetes MellitusDry Socket

Condition Hierarchy (Ancestors)

Glucose Metabolism DisordersMetabolic DiseasesNutritional and Metabolic DiseasesEndocrine System DiseasesMouth DiseasesStomatognathic Diseases

Study Officials

  • Andree Hillebrecht, Dr. med.

    University of Giessen

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
INVESTIGATOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER

Study Record Dates

First Submitted

June 9, 2011

First Posted

June 21, 2011

Study Start

April 1, 2011

Primary Completion

November 1, 2011

Study Completion

June 1, 2012

Last Updated

June 23, 2011

Record last verified: 2011-04

Locations

DE(2)