Type 2 Diabetes and Exercise Function in Single Leg Exercises

NCT01793909 | Completed Results DMC

• 3 other identifiers: 06-006215641UL1TR001082
• Study Type: interventional
• Target: 55
• Locations: 1 country
• Sites: 1

Brief Summary

This study plans to learn more about the effects of type 2 diabetes (T2DM) on exercise blood flow and muscle oxygen uptake. This study will evaluate \& compare exercise function during single leg plantar flexion exercise in a total of 45 subjects from the Denver area (15 lean controls, 15 people with T2DM, and 15 overweight control subjects). Differences between the exercise responses in people with T2DM and healthy people will help further identify the disease process of T2DM and direct future research of treatments and interventions.

Conditions

Type 2 Diabetes

Keywords

Type 2 Diabetes; Exercise Impairment; Blood Flow; Muscle Oxygen Uptake; Exercise Training

Outcome Measures

Primary Outcomes (1)

• Change in Muscle Oxygen Saturation

  The investigators evaluated the dynamics of muscle deoxygenation (O2 extraction) using near infrared spectroscopy (NIRS) during single leg plantar flexion exercise to identify the predominant mechanisms of oxygen delivery versus oxygen utilization abnormalities in the muscle of T2DM during the transition from rest to exercise. These measurements were gathered continuously for 2-5 minutes of multiple exercise bouts within two visits, one prior to the exercise intervention period and one post exercise intervention.

  4.5 hrs each, pre- and post- Exercise Intervention

Study Arms (1)

Single Leg Exercise

OTHER

Supervised single leg, exercise training of the index (dominant) calf muscle 5 days per week for two weeks - alternating weight-bearing single leg calf raises and single leg calf extensions by endurance resistance training (weight machine apparatus).

Other: Single Leg Exercise Training

Interventions

Single Leg Exercise Training OTHER

Following the completion of baseline testing, all 3 subject groups will undergo supervised single leg, exercise training of the index (dominant) calf muscle 5 days per week for two weeks - alternating weight-bearing single leg calf raises and single leg calf extensions by endurance resistance training (weight machine apparatus).

Also known as: Exercise Training

Single Leg Exercise

Eligibility Criteria

• Age: 30 Years - 70 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Men and women with and without type 2 diabetes
• years of age
• Lean and overweight
• Sedentary subjects not participating in a regular exercise program (\<one bout of exercise/week)

You may not qualify if:

• Documented cardiovascular disease
• Uncontrolled hypertension: systolic blood pressure (SBP) \> 150, diastolic blood pressure (DBP)\> 110
• Obstructive pulmonary disease or asthma
• Peripheral neuropathy
• Subjects taking beta blockers, insulin, or Thiazolidinediones (TZD)
• Current or past smoking within the last 2 years
• Anemia
• Control HbA1c \> 6, T2DM HbA1c \> 10
• Type 1 diabetes
• Any implanted metal in subject's body

Sponsors & Collaborators

• University of Colorado, Denver: lead

Study Sites (1)

University of Colorado Denver, Anschutz Medical Campus

Aurora, Colorado, 80045, United States

Location

MeSH Terms

Conditions

Diabetes Mellitus, Type 2

Interventions

Exercise

Condition Hierarchy (Ancestors)

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

Intervention Hierarchy (Ancestors)

Motor Activity; Movement; Musculoskeletal Physiological Phenomena; Musculoskeletal and Neural Physiological Phenomena

Results Point of Contact

• Title: Dr. Judy Regensteiner
• Organization: University of Colorado

judy.regensteiner@ucdenver.edu

303-724-2247

Study Officials

• Judy Regensteiner, PhD

  University of Colorado, Denver

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: No

Study Design

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

Study Record Dates

• First Submitted: December 11, 2012
• First Posted: February 18, 2013
• Study Start: June 1, 2012
• Primary Completion: May 31, 2018
• Study Completion: May 31, 2018
• Last Updated: July 12, 2023
• Results First Posted: May 20, 2019

Record last verified: 2023-07

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)