Resistance Exercise in Already-active Diabetic Individuals (READI) Trial

NCT00410436 | Completed Phase 4 DMC

• 2 other identifiers: 2005301-01H2005783
• Study Type: interventional
• Target: 131
• Locations: 1 country
• Sites: 3

Brief Summary

The purpose of the READI tiral is to examine the effects of resistance training (weight training) on the blood sugar control of aerobically active individuals with Type 1 Diabetes.

Conditions

Diabetes

Keywords

Type 1 Diabetes; Resistance Exercise; Aerobic Exercise

Outcome Measures

Primary Outcomes (1)

• Change in HbA1c

  Change in HbA1c from pre and post-intervention

  6-months

Secondary Outcomes (3)

• body composition,LDL particle diameter,apolipoprotein B (Apo-B)

  6-months

• apolipoprotein A1 (Apo-A1,Apo-B/Apo-A1 ratio,urinary albumin excretion

  6-months

• serum C-reactive protein,

  6-months

Study Arms (2)

Resistance Training Group

EXPERIMENTAL

Resistance Training (R) 3X/week progressing to 3 sets, 8 repetitions of 8 exercises at the maximum load that can be lifted 8 times in a controlled manner, maintaining proper form (8RM).

Behavioral: Resistance Exercise

Control Group

ACTIVE COMPARATOR

Subjects will not be performing resistance exercise but will continue performing aerobic exercise at the same volume, duration and intensity as they did at baseline.

Behavioral: Resistance Exercise

Interventions

Resistance Exercise BEHAVIORAL

Subjects demonstrating adequate compliance during the run-in period will then be randomized in equal numbers to Resistance Training (R) 3X/week progressing to 3 sets, 8 repetitions of 8 exercises at the maximum load that can be lifted 8 times in a controlled manner, maintaining proper form (8RM), or waiting-list control (C).

Also known as: non applicable

Control Group; Resistance Training Group

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 with duration \≥1 year, requiring insulin therapy starting within one year of diagnosis and continuously thereafter.
• Male or female, age \≥16 years, HbA1c 0.066-0.099 (normal non-diabetic range 0.040-0.060).
• Habitual performance during the previous 4 months of exercise \≥3 times per week, including at least 90 minutes per week of vigourous aerobic exercise (of sufficient intensity to cause sweating; e.g. jogging, soccer, basketball, racquet sports), and/or \≥150 minutes per week of aerobic exercise of at least moderate intensity (e.g. brisk walking, moderate-paced bicycling) but no resistance training. Subjects must agree to maintain their habitual volume and intensity of aerobic activity during run-in and intervention periods, minimizing variation due to seasons, but they will be permitted to vary specific exercises chosen.
• Willingness and ability to work closely with the study physicians, nurse and dietitian and follow their recommendations for insulin therapy and adjustments of diet.

You may not qualify if:

• Participation during the previous 4 months 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 \>35 kg/m2, or weight \>147 kg (exceeding capacity of DEXA or CT scanners)
• Fasting serum c-peptide \0.2 nmol/l.
• Increase or decrease of \5% of body weight during the previous two months.
• 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 \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.
• Pregnancy at the start of the study, or intention to become pregnant in the next year.

Sponsors & Collaborators

• Ottawa Hospital Research Institute: lead
• Canadian Institutes of Health Research (CIHR): collaborator

Study Sites (3)

University of Calgary

Calgary, Alberta, T3R 0X7, Canada

Location

Ottawa Health Research Institute

Ottawa, Ontario, K1H 7W9, Canada

Location

University Health Network

Toronto, Ontario, M5G 2C4, Canada

Location

MeSH Terms

Conditions

Diabetes Mellitus; Diabetes Mellitus, Type 1

Interventions

Resistance Training

Condition Hierarchy (Ancestors)

Glucose Metabolism Disorders; Metabolic Diseases; Nutritional and Metabolic Diseases; Endocrine System Diseases; Autoimmune Diseases; Immune System Diseases

Intervention Hierarchy (Ancestors)

Exercise Therapy; Rehabilitation; Aftercare; Continuity of Patient Care; Patient Care; Therapeutics; Physical Therapy Modalities; Physical Conditioning, Human; Exercise; Motor Activity; Movement; Musculoskeletal Physiological Phenomena; Musculoskeletal and Neural Physiological Phenomena

Study Officials

• Ron Sigal, MD

  OHRI

  STUDY CHAIR

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: December 8, 2006
• First Posted: December 12, 2006
• Study Start: October 1, 2006
• Primary Completion: December 1, 2011
• Study Completion: June 1, 2012
• Last Updated: February 27, 2013

Record last verified: 2013-02

Locations

CA (3)