Recruiting

Type 2 Diabetes

Sponsor:

University of Massachusetts, Amherst

Code:

NCT03940937

Conditions

Type 2 Diabetes Mellitus

Walking

Eligibility Criteria

Sex: All

Age: 40 - 65

Healthy Volunteers: Not accepted

Study Details

Brief summary:

The purpose of this study is to measure and link cadence (number of steps taken in a minute) to intensity of physical activity (e.g., low-intensity, moderate intensity, vigorous-intensity) in adults (40- 65 years-old) with type 2 diabetes.

Conditions

Type 2 Diabetes Mellitus

Walking

Study ID

NCT03940937

Start date

May, 2019

Status verified date

May, 2019

Completion date

Oct, 2019

Anticipated

Primary completion date

Oct, 2019

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 40 - 65

Healthy Volunteers: Not accepted

Inclusion Criteria:

  • Able to ambulate on a treadmill (self-reported)
  • Diagnosed with type 2 diabetes (self-reported)
  • Self-report participating in less than 30 minutes of moderate intensity exercise per day for most days of the week
  • Able to fast for at least 4 hours prior to study visit involving the treadmill protocol
  • Self-report having an HbA1c measure greater than 7% in the past 6 months

Exclusion Criteria:

  • BMI - <18.5kg/m² or >40kg/m²
  • Tobacco use - Currently a smoker or have smoked tobacco within the past 6 months.
  • Insulin - Those with type 2 diabetes being controlled with insulin
  • Ambulatory ability - Since the focus herein is on ambulatory activities, participants who use wheelchairs or other impairments that prevent normal ambulation will be excluded. This criterion is similar to that used by NHANES when selecting individuals (up to 85 years of age) to wear motion sensors.
  • Resting Blood Pressure - Systolic blood pressure greater than 159 mmHg or diastolic blood pressure greater than 99mmHg
  • Abnormal resting ECG (evaluated by physician) will be advised to see personal physician (participant provided with resting ECG results)
  • Any condition/medication that may affect heart rate response to exercise testing.
  • Current participation in any other study protocol which involves taking an experimental medication
  • Hospitalization for mental illness within the past 5 years.
  • Previous history of, or clinical symptoms or signs of, cardiovascular disease, stroke or transient ischemic attacks (TIAs), chest pain, unusual dyspnea during physical activity/ exercise, severe ankle edema, or intermittent claudication.
  • Previous history of musculoskeletal injuries or problems causing severe pain during physical activity or exercise which interferes with daily activities.
  • Participant experiences dizziness or balance impairment at rest or with exercise
  • Participant is currently treated for kidney disease with dialysis, or has severe liver damage? (e.g., liver cirrhosis)
  • Participant has a pacemaker or other implanted medical device (including metal joint replacements).
  • Participant has chronic lung problems that make it difficult to breathe (e.g., Chronic Respiratory Diseases, Cystic Fibrosis, chronic obstructive pulmonary disease \[COPD\] or uses supplemental O2)
  • Participant has Cancer treated with chemotherapy that affects breathing or heart rate
  • Participant experiences shortness or breath at rest or during mild exertion
  • Participant is pregnant.
  • Participant is unable to complete all testing within a maximal two-week period
  • Individuals wearing a full beard may need to be excluded from the study, as large amounts of facial hair around the mouth and nose interfere with the seal of the device that measures the air being breathed. Because of this we are seeking participants that are clean shaven or with a beard where areas around the nose and mouth are clean shaven (e.g. goatee).
  • Any significant medical condition that may interfere with the study.

Study Design

Enrollment

20 participants

Anticipated

Interventions and Outcome Measures

Primary outcome measure

  • Cadence (steps/min) [ Time Frame: Through completion of the treadmill walking protocol that occurs during the study visit (approximately 1 hour) ]
  • Oxygen consumption (VO2; mL/kg/min) [ Time Frame: Through completion of the treadmill walking protocol that occurs during the study visit (approximately 1 hour) ]

Central Contacts and Locations

Central contacts

Christopher C Moore, BS

413-545-1583T2DMCadenceStudy@gmail.com

Scott Ducharme, PhD

413-545-1583sducharm@kin.umass.edu

Locations

Totman Building

Recruiting

Amherst, Massachusetts, United States, 01002

Contacts

Christopher C Moore, BS

413-545-1583t2dmcadencestudy@gmail.com

Zach Gould, BS

(413) 545-1583t2dmcadencestudy@gmail.com

More Information

Sponsor

University of Massachusetts, Amherst

Last update posted

May 7, 2019

Last verified

May, 2019

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-10. This information was provided to ClinicalTrials.gov by University of Massachusetts, Amherst on 2019-05-07.