RECRUITING

Exercise and Time of Day in Type 2 Diabetes

Study Overview

This clinical trial focuses on testing the efficacy of different digital interventions to promote re-engagement in cancer-related long-term follow-up care for adolescent and young adult (AYA) survivors of childhood cancer.

Description

The overall purpose of the study is to test the effect of Noom on exercise and diet advice in adults with type 2 diabetes. The overarching hypothesis is that the use of Noom may promote better dietary adherence during an exercise program, thereby promoting greater weight loss and cardiometabolic health compared to lifestyle advice only. In particular, the investigators anticipate that changes in metabolic and vascular insulin sensitivity will correlate with glycemic control and blood pressure changes.

Official Title

Exercise Time of Day for Cardiometabolic Health in Type 2 Diabetes

Quick Facts

Study Start:2021-09-25
Study Completion:2025-02-28
Study Type:Not specified
Phase:Not Applicable
Enrollment:Not specified
Status:RECRUITING

Study ID

NCT05108987

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Ages Eligible for Study:30 Years to 70 Years
Sexes Eligible for Study:ALL
Accepts Healthy Volunteers:No
Standard Ages:ADULT, OLDER_ADULT
Inclusion CriteriaExclusion Criteria
  1. * Male or female \>30 and \<70 years old.
  2. * Has a body mass index \>28 and \<45 kg/m2.
  3. * Previously diagnosed with T2DM.
  4. * Subjects currently taking medications that affect heart rate and rhythm (i.e. Ca++ channel blockers, nitrates, alpha- or beta-blockers).
  1. * Morbidly obese patients (BMI \>46 kg/m2) and overweight/lean patients (BMI \<27 kg/m2)
  2. * Evidence of type 1 diabetes and diabetics requiring insulin therapy
  3. * Subjects who have not been weight stable (\>2 kg weight change in past 3 months)
  4. * Subjects who have been recently active (\>30 min of moderate/high intensity exercise, 2 times/week).
  5. * Subjects who are smokers or who have quit smoking \<1 years ago
  6. * Subjects with abnormal estimated glomerular filtration rate (eGFR).
  7. * Hypertriglyceridemic (\>400 mg/dl) and hypercholesterolemic (\>260 mg/dl) subjects
  8. * Hypertensive (\>160/100 mmHg)
  9. * Subjects with a history of significant metabolic, cardiac, congestive heart failure, cerebrovascular, hematological, pulmonary, gastrointestinal, liver, renal, or endocrine disease or cancer that in the investigator's opinion would interfere with or alter the outcome measures or impact subject safety.
  10. * Pregnant (as evidenced by positive urine pregnancy test) or nursing women
  11. * Subjects with contraindications to participation in an exercise training program
  12. * Currently taking active weight suppression medication (e.g. phentermine,orlistat, lorcaserin, naltrexone-bupropion in combination, liraglutide, benzephetamine, diethylpropion, phendimetrazine)
  13. * Known hypersensitivity to perflutren (contained in Definity)

Contacts and Locations

Study Contact

Steven K Malin
CONTACT
848-932-7054
steven.malin@rutgers.edu

Principal Investigator

Steven K Malin, PhD
PRINCIPAL_INVESTIGATOR
Rutgers University - New Brunswick

Study Locations (Sites)

New Jersey Institute for Food, Nutrition, and Health
New Brunswick, New Jersey, 08901
United States
Robert Wood Johnson University Hospital Clinical Research Center
New Brunswick, New Jersey, 08901
United States
Rutgers University Loree Gymnasium
New Brunswick, New Jersey, 08901
United States

Collaborators and Investigators

Sponsor: Rutgers, The State University of New Jersey

  • Steven K Malin, PhD, PRINCIPAL_INVESTIGATOR, Rutgers University - New Brunswick

Study Record Dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Registration Dates

Study Start Date2021-09-25
Study Completion Date2025-02-28

Study Record Updates

Study Start Date2021-09-25
Study Completion Date2025-02-28

Terms related to this study

Keywords Provided by Researchers

  • type 2 diabetes
  • diet
  • exercise
  • mobile application
  • cardiometabolic
  • metabolic health
  • behavioral
  • vascular health
  • blood flow
  • continuous glucose monitoring

Additional Relevant MeSH Terms

  • Diabetes Mellitus, Type 2
  • Metabolic Syndrome