Working…
ClinicalTrials.gov
ClinicalTrials.gov Menu

Cadence and Intensity in Adults With Type 2 Diabetes (CADENCE-T2DM)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT03940937
Recruitment Status : Unknown
Verified May 2019 by Stuart R Chipkin, University of Massachusetts, Amherst.
Recruitment status was:  Recruiting
First Posted : May 7, 2019
Last Update Posted : May 7, 2019
Sponsor:
Information provided by (Responsible Party):
Stuart R Chipkin, University of Massachusetts, Amherst

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.

Condition or disease
Type 2 Diabetes Mellitus Walking

Show Show detailed description

Layout table for study information
Study Type : Observational
Estimated Enrollment : 20 participants
Observational Model: Cohort
Time Perspective: Cross-Sectional
Official Title: Cadence and Intensity in Adults With Type 2 Diabetes
Estimated Study Start Date : May 2019
Estimated Primary Completion Date : October 2019
Estimated Study Completion Date : October 2019

Resource links provided by the National Library of Medicine





Primary Outcome Measures :
  1. Cadence (steps/min) [ Time Frame: Through completion of the treadmill walking protocol that occurs during the study visit (approximately 1 hour) ]
    Cadence (steps/min) as assessed by direct observation of steps (hand-tallied counts) divided by time

  2. Oxygen consumption (VO2; mL/kg/min) [ Time Frame: Through completion of the treadmill walking protocol that occurs during the study visit (approximately 1 hour) ]
    The amount of oxygen consumed, as measured with indirect calorimetry, expressed per unit of body mass



Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


Layout table for eligibility information
Ages Eligible for Study:   40 Years to 65 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Sampling Method:   Non-Probability Sample
Study Population
A convenience sample from the surrounding community consisting of twenty 40-65 yr old adults (10 men, 10 women) with pharmacologically-controlled type 2 diabetes (not using insulin). Participants must self-report being non-active (less than 30 minutes of moderate intensity exercise per day for most days of the week) and to have an HbA1c not at goal (therefore >7%) in the past 6 months.
Criteria

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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03940937


Contacts
Layout table for location contacts
Contact: Christopher C Moore, BS 413-545-1583 T2DMCadenceStudy@gmail.com
Contact: Scott Ducharme, PhD 413-545-1583 sducharm@kin.umass.edu

Locations
Layout table for location information
United States, Massachusetts
Totman Building Recruiting
Amherst, Massachusetts, United States, 01002
Contact: Christopher C Moore, BS    413-545-1583    t2dmcadencestudy@gmail.com   
Contact: Zach Gould, BS    (413) 545-1583    t2dmcadencestudy@gmail.com   
Sponsors and Collaborators
University of Massachusetts, Amherst
Investigators
Layout table for investigator information
Principal Investigator: Stuart C Chipkin, MD University of Massachusetts Amherst, Department of Kinesiology
Additional Information:
Publications:
Layout table for additonal information
Responsible Party: Stuart R Chipkin, Research Professor, University of Massachusetts, Amherst
ClinicalTrials.gov Identifier: NCT03940937    
Other Study ID Numbers: CADENCE-T2DM
First Posted: May 7, 2019    Key Record Dates
Last Update Posted: May 7, 2019
Last Verified: May 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

Layout table for additional information
Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Additional relevant MeSH terms:
Layout table for MeSH terms
Diabetes Mellitus
Diabetes Mellitus, Type 2
Glucose Metabolism Disorders
Metabolic Diseases
Endocrine System Diseases