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Type 1 Diabetes Aerobic and Resistance Exercise (T1-DARE)

NCT00148538 · Status: COMPLETED · Phase: PHASE3 · Type: INTERVENTIONAL · Enrollment: 66

Last updated 2019-07-23

No results posted yet for this study

Summary

This is a randomized controlled trial evaluating different exercise modalities in previously inactive subjects with type 1 diabetes.

The primary objective of this study is to determine the effects of resistance exercise training, and of aerobic exercise training, on glycemic control (A1c) in previously inactive individuals with type 1 diabetes, with background therapy meeting modern standards, including multiple daily insulin injections or insulin pump, carbohydrate counting, frequent glucose monitoring, and utilization of glucose monitoring to adjust CHO and insulin for exercise.

Secondary aims: In type 1 diabetic individuals receiving therapy meeting the criteria above, to determine the effects of resistance exercise training and aerobic exercise training on frequency of hypoglycemia, body composition, lipids, C-reactive protein and quality of life.

Hypotheses:

1. Subjects randomized to resistance exercise (R and AR combined) will have greater reductions in A1c than in those not randomized to resistance exercise (A and C combined).
2. Subjects randomized to aerobic exercise (A and AR combined) will show a trend to greater HbA1c reduction than those not randomized to aerobic exercise (R and C combined).

Secondary hypotheses: We expect that both aerobic and resistance exercise will show trends to improvement in most listed secondary outcomes.

Conditions

  • Diabetes Mellitus, Type 1

Interventions

BEHAVIORAL

Resistance and/or Aerobic Exercise

Resistance and/or Aerobic Exercise

Sponsors & Collaborators

  • Ottawa Hospital Research Institute

    lead OTHER

Principal Investigators

  • Ronald J Sigal · The Ottawa Health Research Institute, The Ottawa Hospital, The University of Ottawa

  • Gary Goldfield · Children's Hospital of Eastern Ontario

  • Glen Kenny · University of Ottawa

  • Stasia Hadjiyannakis · Children's Hospital of Eastern Ontario

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
SINGLE
Model
PARALLEL

Eligibility

Min Age
16 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2005-07-31
Primary Completion
2010-12-31
Completion
2012-04-30

Countries

  • Canada

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT00148538 on ClinicalTrials.gov