Barriers to Physical Activity in People With Type 2 Diabetes

NCT01701570 | Completed

• 2 other identifiers: 11-09096147
• Study Type: interventional
• Target: 35
• Locations: 1 country
• Sites: 1

Brief Summary

The investigators plan to learn more about how different levels of exercise feel to people with Type 2 Diabetes and how it feels to people without Type 2 Diabetes. This study team will also look at what causes exercise to feel harder or easier to people with and without Type 2 Diabetes. The investigators will also compare the potential benefits of supervised exercise training to that of diabetes education/blood sugar monitoring.

Conditions

Type 2 Diabetes

Keywords

Type 2 Diabetes; Exercise; Rate of Perceived Exertion

Outcome Measures

Primary Outcomes (1)

• Rating of perceived exercise effort (RPE) during exercise (Borg RPE scale)

  RPE was developed by Dr. Gunnar Borg and is a validated, self-reported measure of perceived effort during exercise. Possible scores range from 6 (no effort, resting) to 20 (maximal effort). Change = RPE post-intervention (week 20) - RPE baseline.

  Baseline, week 20

Secondary Outcomes (1)

• Serum lactate during exercise

  Baseline, week 20

Study Arms (2)

An Active Comparator exercise training intervention

ACTIVE COMPARATOR

The Active Comparator Groupwill participate in an exercise training intervention to distinguish the relative roles of objective factors (lactate level) and subjective factors (self-efficacy) in mediating pre-post change in RPE during low, moderate, and vigorous exercise.

Other: Supervised Exercise Training

A Placebo Attention Control

PLACEBO COMPARATOR

The placebo attention control group will receive monthly diabetes education and phone calls phone calls to monitor their blood glucose levels. Participants will receive an accelerometer to wear for one week.

Behavioral: Placebo Attention Control

Interventions

Placebo Attention Control BEHAVIORAL

The placebo attention control group will receive weekly phone calls to monitor their blood glucose levels.

A Placebo Attention Control

Supervised Exercise Training OTHER

The 20-week aerobic exercise training intervention provides supervised exercise training sessions 3 times weekly following the HERITAGE study training model that was feasible in prior studies with older, sedentary overweight adults (55%maximal oxygen uptake (VO2max) for 30 minutes per session at study entry with progressive titration to 70-80% VO2max for 50 minutes).

An Active Comparator exercise training intervention

Eligibility Criteria

• Age: 50 Years - 70 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Sedentary men and women not participating in a regular exercise program (\> 60 minutes of exercise per week)
• If subject has diabetes,
• must be uncomplicated type 2 diabetes (T2D) and
• \<15 years since T2D diagnosis.
• Ages of 50-70 years
• BMI between 25 and 35
• Subjects can only be taking the following oral hypoglycemic drugs:
• metformin,
• sulfonylureas or
• sitagliptin.
• Persons with T2D only if they have total glycosylated hemoglobin levels (HbA1C) \<8.0% (adequate control) on therapy.
• Control subjects must have:
• HbA1C \< 5.7% and
• a fasting blood glucose of \<100 mg/dl suggesting no significant insulin resistance.
• All women must be post-menopausal, documented by menstrual history and follicle stimulating hormone (FSH) level.

You may not qualify if:

• Persons with clinically evident distal symmetrical neuropathy, determined by evaluation of symptoms (numbness, paresthesia) and signs (elicited by vibration, pinprick, light touch, ankle jerks), will be excluded from further study as neuropathy may limit exercise performance.
• Specifically, if monofilament sensation is absent at the level of the ankles, then participants will be excluded from study participation.
• Persons with autonomic dysfunction (\>20 mm fall in upright BP without a change in heart rate) will be excluded as well, due to associated limitations of exercise performance.
• Current use of insulin or other oral hypoglycemic medications.
• Current smokers will be excluded since smoking can impair cardiovascular (CV) exercise performance
• Persons will be excluded if they have:
• evidence of heart disease by history (Prior heart attack or bypass surgery, heart failure, or significant valvular disease) or
• abnormal resting electrocardiogram (EKG) consistent with prior infarct or latent ischemia (unless cardiovascular stress imaging or catheterization shows they do not have coronary artery disease).
• left or right bundle branch block on resting EKG (precludes recognition of ischemic EKG changes with exercise) or
• abnormal exercise EKG (\> 1 mm ST segment depression 80 msec out in the ST segment for 3 consecutive beats).
• Persons with angina or any other exercise-limiting cardiovascular, pulmonary or musculoskeletal symptoms.
• Presence of:
• systolic blood pressure \>145 mm Hg at rest or \>250 mm Hg with exercise or
• diastolic blood pressure \>90 mm Hg at rest or \>115 mm Hg with exercise.
• Subjects with:

Sponsors & Collaborators

• University of Colorado, Denver: lead
• Colorado Clinical & Translational Sciences Institute: collaborator

Study Sites (1)

University of Colorado, Anschutz Medical Campus

Aurora, Colorado, 80045, United States

Location

MeSH Terms

Conditions

Diabetes Mellitus, Type 2; Motor Activity

Condition Hierarchy (Ancestors)

Diabetes Mellitus; Glucose Metabolism Disorders; Metabolic Diseases; Nutritional and Metabolic Diseases; Endocrine System Diseases; Behavior

Study Officials

• Amy Huebschmann, MD

  University of Colorado, Denver

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: June 13, 2012
• First Posted: October 5, 2012
• Study Start: April 1, 2012
• Primary Completion: August 1, 2018
• Study Completion: August 1, 2018
• Last Updated: October 14, 2022

Record last verified: 2022-10

Locations

US (1)