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

NCT00148538 | Completed Phase 3

• 1 other identifier: GA-3-05-1903-RS
• Study Type: interventional
• Target: 66
• Locations: 1 country
• Sites: 1

Brief 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. 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. 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).

Conditions

Diabetes Mellitus, Type 1

Keywords

Type 1 Diabetes; Resistance Exercise; Aerobic Exercise; Exercise & Disease; Exercise; Diabetes

Outcome Measures

Primary Outcomes (1)

• HbA1c at the end of the 6-month exercise period

  end of study

Secondary Outcomes (10)

• frequency of hypoglycemia

  end of study

• fructosamine

  end of study

• blood pressure

  end of study

• lipid concentrations

  end of study

• apolipoproteins A1 and B

  end of study

Study Arms (2)

1

ACTIVE COMPARATOR

resistance exercise

Behavioral: Resistance and/or Aerobic Exercise

2

ACTIVE COMPARATOR

Aerobic and Resistance exercise

Behavioral: Resistance and/or Aerobic Exercise

Interventions

Resistance and/or Aerobic Exercise BEHAVIORAL

Resistance and/or Aerobic Exercise

Also known as: non applicable

1; 2

Eligibility Criteria

• Age: 16 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

• Type 1 diabetes mellitus as defined by the 2003 CDA guidelines (16) requiring insulin therapy starting within one year of diagnosis and continuously thereafter
• Male or female, age 16-45 years, A1c 0.066-0.090

You may not qualify if:

• Willingness and ability to work closely with the study physicians, nurse and dietitian and follow intensive diabetes therapy including carbohydrate counting, glucose monitoring ≥ 4 times per day, and intensive insulin therapy--either by multiple daily injections (MDI--insulin aspart or lispro before meals and NPH or insulin glargine 1-2X/day) or continuous subcutaneous insulin infusion (CSII) by pump therapy using insulin aspart or lispro for the duration of involvement in the study. CSII will only be an option for those already on CSII prior to entry in the study.
• Participation during the previous 4 months in a regular program of exercise or aerobic sports greater than 2 times per week for at least 20 minutes per session, or in any resistance training.
• Hypoglycemia unawareness, or severe hypoglycemia requiring assistance from another person within the previous 3 months.
• "Brittle" diabetes, characterized by frequent and unpredictable hypoglycemia (even if not requiring assistance from others) and hyperglycemia.
• Restrictions in physical activity due to disease: intermittent claudication, severe peripheral neuropathy or active proliferative retinopathy, unstable cardiac or pulmonary disease, disabling stroke, severe arthritis.
• Known or suspected clinically significant gastroparesis.
• Body mass index less than or equal to 32 kg/m2.
• Fasting serum c-peptide less than 0.2 nmol/l.
• Recent significant weight change (increase or decrease of 5% of body weight during the two months before enrollment).
• An expected requirement within the subsequent 6 months for medications (other than insulin) that will affect glucose metabolism (e.g. corticosteroids).
• If age \< 18 yr, linear growth of 1cm during the previous year.
• Significant renal disease: serum creatinine greater than 200 mEq/l. or proteinuria \> 1 g/24 hours.
• Uncontrolled hypertension: BP \> 150 mm Hg systolic or \> 95 mm Hg diastolic in a sitting position.
• Other illness, judged by the patient or investigators to make participation in this study inadvisable.
• Cognitive deficit resulting in inability to understand or comply with instructions.

Sponsors & Collaborators

• Ottawa Hospital Research Institute: lead

Study Sites (1)

Ottawa Health Research Institute

Ottawa, Ontario, K1Y 4E9, Canada

Location

Related Links

• Related Info

MeSH Terms

Conditions

Diabetes Mellitus, Type 1; Motor Activity; Disease; Diabetes Mellitus

Condition Hierarchy (Ancestors)

Glucose Metabolism Disorders; Metabolic Diseases; Nutritional and Metabolic Diseases; Endocrine System Diseases; Autoimmune Diseases; Immune System Diseases; Behavior; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Study Officials

• Ronald J Sigal

  The Ottawa Health Research Institute, The Ottawa Hospital, The University of Ottawa

  PRINCIPAL INVESTIGATOR

• Gary Goldfield

  Children's Hospital of Eastern Ontario

  PRINCIPAL INVESTIGATOR

• Glen Kenny

  University of Ottawa

  PRINCIPAL INVESTIGATOR

• Stasia Hadjiyannakis

  Children's Hospital of Eastern Ontario

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: September 6, 2005
• First Posted: September 8, 2005
• Study Start: July 1, 2005
• Primary Completion: December 1, 2010
• Study Completion: April 1, 2012
• Last Updated: July 23, 2019

Record last verified: 2019-07

Locations

CA (1)