Exercise and Time of Day in Type 2 Diabetes

NCT05108987 | Recruiting

• 1 other identifier: Pro2021001183
• Study Type: interventional
• Target: 30
• Locations: 1 country
• Sites: 3

Brief Summary

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.

Conditions

Diabetes Mellitus, Type 2; Metabolic Syndrome

Keywords

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

Outcome Measures

Primary Outcomes (1)

• Body Weight

  The primary outcome is changes in body weight pre- and post-intervention

  Over the course of 2 weeks.

Secondary Outcomes (2)

• Glucose Tolerance

  Over the course of 2 weeks.

• Flow-mediated dilation

  Over the course of 2 weeks.

Study Arms (2)

Morning Exercise

EXPERIMENTAL

If subjects are randomly assigned to this group, they will participate in exercise training in the morning at a moderate to hard intensity. Subjects will be asked to regularly engage in morning exercise while supervised for about 2 weeks.

Behavioral: Morning Exercise

Afternoon Exercise

ACTIVE COMPARATOR

If subjects are assigned to this group, they will participate in the same exercise program but after in the afternoon.

Behavioral: Afternoon Exercise

Interventions

Morning Exercise BEHAVIORAL

Exercise at moderate to hard intensity will be performed in the morning for up to 10 sessions for about 1 hour under supervision in the morning.

Morning Exercise

Afternoon Exercise BEHAVIORAL

Exercise at moderate to hard intensity will be performed in the morning for up to 10 sessions for about 1 hour under supervision in the afternoon.

Afternoon Exercise

Eligibility Criteria

• Age: 30 Years - 70 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Male or female \>30 and \<70 years old.
• Has a body mass index \>28 and \<45 kg/m2.
• Previously diagnosed with T2DM.
• Subjects currently taking medications that affect heart rate and rhythm (i.e. Ca++ channel blockers, nitrates, alpha- or beta-blockers).

You may not qualify if:

• Morbidly obese patients (BMI \>46 kg/m2) and overweight/lean patients (BMI \<27 kg/m2)
• Evidence of type 1 diabetes and diabetics requiring insulin therapy
• Subjects who have not been weight stable (\>2 kg weight change in past 3 months)
• Subjects who have been recently active (\>30 min of moderate/high intensity exercise, 2 times/week).
• Subjects who are smokers or who have quit smoking \<1 years ago
• Subjects with abnormal estimated glomerular filtration rate (eGFR).
• Hypertriglyceridemic (\>400 mg/dl) and hypercholesterolemic (\>260 mg/dl) subjects
• Hypertensive (\>160/100 mmHg)
• 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.
• Pregnant (as evidenced by positive urine pregnancy test) or nursing women
• Subjects with contraindications to participation in an exercise training program
• Currently taking active weight suppression medication (e.g. phentermine,orlistat, lorcaserin, naltrexone-bupropion in combination, liraglutide, benzphetamine, diethylpropion, phendimetrazine)
• Known hypersensitivity to perflutren (contained in Definity)

Sponsors & Collaborators

• Rutgers, The State University of New Jersey: lead
• Noom Inc.: collaborator

Study Sites (3)

New Jersey Institute for Food, Nutrition, and Health

New Brunswick, New Jersey, 08901, United States

RECRUITING

Robert Wood Johnson University Hospital Clinical Research Center

New Brunswick, New Jersey, 08901, United States

RECRUITING

Rutgers University Loree Gymnasium

New Brunswick, New Jersey, 08901, United States

RECRUITING

MeSH Terms

Conditions

Diabetes Mellitus, Type 2; Metabolic Syndrome; Motor Activity; Behavior

Condition Hierarchy (Ancestors)

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

Study Officials

• Steven K Malin, PhD

  Rutgers University - New Brunswick

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Steven K Malin

CONTACT

848-932-7054; steven.malin@rutgers.edu

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Associate Professor

Study Record Dates

• First Submitted: October 26, 2021
• First Posted: November 5, 2021
• Study Start: September 25, 2021
• Primary Completion: December 31, 2025
• Study Completion: February 28, 2026
• Last Updated: June 15, 2025

Record last verified: 2025-06

Data Sharing

• IPD Sharing: Will not share

Locations

US (3)