Exercise and Time of Day in Type 2 Diabetes

NCT05108987 | Completed

• 1 other identifier: Pro2021001183
• Study Type: interventional
• Target: 36
• Locations: 1 country
• Sites: 3

Brief Summary

The overall purpose of the study is to test the effect exercise time of day in adults with type 2 diabetes or prediabetes. The overarching hypothesis is that afternoon exercise in the afternoon may promote better changes in metabolic and vascular insulin sensitivity. We anticipate that these changes will correlate with glycemic control and blood pressure changes.

Conditions

PreDiabetes; Diabetes Mellitus, Type 2

Keywords

type 2 diabetes; exercise; 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 participants are randomly assigned to this group, they will participate in exercise training in the morning (between 7:00am - 11:00am) at an exercise intensity \~85% VO2max. Participants will be asked to regularly engage in morning exercise while supervised for about 2 weeks.

Behavioral: Morning Exercise

Afternoon Exercise

ACTIVE COMPARATOR

If participants are randomly assigned to this group, they will participate in exercise training in the afternoon (between 4:00pm - 8:00pm) at an exercise intensity \~85% VO2max. Participants will be asked to regularly engage in afternoon exercise while supervised for about 2 weeks.

Behavioral: Afternoon Exercise

Interventions

Morning Exercise BEHAVIORAL

Sixty minutes of supervised exercise at an intensity \~85% VO2max will be performed in the morning (between 7:00am - 11:00am) for up to 10 sessions.

Morning Exercise

Afternoon Exercise BEHAVIORAL

Sixty minutes of supervised exercise at an intensity \~85% VO2max will be performed in the afternoon (between 4:00pm - 8:00pm) for up to 10 sessions.

Afternoon Exercise

Eligibility Criteria

• Age: 30 Years - 80 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Male or female \>30 and \<80 years old.
• Has a body mass index \>25 and \<45 kg/m2.
• Previously diagnosed with prediabetes and/or T2D.
• If not previously diagnosed, has a fasting blood glucose ≥ 100 mg/dL and/or HbA1c ≥ 5.7%

You may not qualify if:

• Morbidly obese patients (BMI \>45 kg/m2) and lean patients (BMI \<25 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, 3 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, 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

Study Sites (3)

New Jersey Institute for Food, Nutrition, and Health

New Brunswick, New Jersey, 08901, United States

Location

Robert Wood Johnson University Hospital Clinical Research Center

New Brunswick, New Jersey, 08901, United States

Location

Rutgers University Loree Gymnasium

New Brunswick, New Jersey, 08901, United States

Location

MeSH Terms

Conditions

Diabetes Mellitus, Type 2; Prediabetic State; Motor Activity; Behavior

Condition Hierarchy (Ancestors)

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

Study Officials

• Steven K Malin, PhD

  Rutgers University - New Brunswick

  PRINCIPAL INVESTIGATOR

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: Professor

Study Record Dates

• First Submitted: October 26, 2021
• First Posted: November 5, 2021
• Study Start: September 25, 2021
• Primary Completion: December 17, 2025
• Study Completion: December 18, 2025
• Last Updated: May 18, 2026

Record last verified: 2026-05

Data Sharing

• IPD Sharing: Will not share

Locations

US (3)