Exercise and Time of Day in Type 2 Diabetes
Primary Purpose
Diabetes Mellitus, Type 2, Metabolic Syndrome
Status
Recruiting
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Exercise Morning
Exercise Afternoon
Sponsored by
About this trial
This is an interventional treatment trial for Diabetes Mellitus, Type 2 focused on measuring type 2 diabetes, diet, exercise, mobile application, cardiometabolic, metabolic health, behavioral, vascular health, blood flow, continuous glucose monitoring
Eligibility Criteria
Inclusion Criteria:
- 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).
Exclusion Criteria:
- 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, benzephetamine, diethylpropion, phendimetrazine)
- Known hypersensitivity to perflutren (contained in Definity)
Sites / Locations
- New Jersey Institute for Food, Nutrition, and HealthRecruiting
- Robert Wood Johnson University Hospital Clinical Research CenterRecruiting
- Rutgers University Loree GymnasiumRecruiting
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Active Comparator
Arm Label
Exercise Morning
Exercise Afternoon
Arm Description
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.
If subjects are assigned to this group, they will participate in the same exercise program but after in the afternoon.
Outcomes
Primary Outcome Measures
Body Weight
The primary outcome is changes in body weight pre- and post-intervention
Secondary Outcome Measures
Glucose Tolerance
We will examine the influence of Noom on the glucose area under the curve during the oral glucose tolerance test.
Flow-mediated dilation
We will assess blood flow to better understand nutrient/glucose delivery.
Full Information
NCT ID
NCT05108987
First Posted
October 26, 2021
Last Updated
May 2, 2023
Sponsor
Rutgers, The State University of New Jersey
Collaborators
Noom Inc.
1. Study Identification
Unique Protocol Identification Number
NCT05108987
Brief Title
Exercise and Time of Day in Type 2 Diabetes
Official Title
Exercise Time of Day for Cardiometabolic Health in Type 2 Diabetes
Study Type
Interventional
2. Study Status
Record Verification Date
May 2023
Overall Recruitment Status
Recruiting
Study Start Date
September 25, 2021 (Actual)
Primary Completion Date
September 25, 2024 (Anticipated)
Study Completion Date
September 25, 2025 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Rutgers, The State University of New Jersey
Collaborators
Noom Inc.
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Product Manufactured in and Exported from the U.S.
Yes
Data Monitoring Committee
No
5. Study Description
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.
Detailed Description
Type 2 diabetes (T2D) is associated with a 3-fold cardiovascular disease (CVD) mortality risk compared with healthy controls, and it is estimated that 30 million adults in the United States have the disease. In recent years the American Diabetes Association (ADA) and American College of Sports Medicine (ACSM) recommend moderate intensity (40-60% heart rate max, HRmax) aerobic exercise 3-5d/wk for the management of T2D. The statement also recognized that higher exercise intensity (>60% HRmax) predicts better blood glucose control than exercise volume. Cardiovascular health (e.g. fitness, blood pressure, etc.) also appears to respond in an exercise dose dependent manner. Despite these suggestions, many people exercising compensate by eating calories back from exercise, thereby negating weight loss. Moreover, compliance and adherence to exercise and diet medical counsel is disappointingly low.
Recent work has begun to target the best time of day to exercise in effort to improve weight loss and related health. This has evolved in part since circadian biology reveals people tend to become glucose intolerant, and develop insulin resistance and endothelial dysfunction in the evening compared with morning. As a result, it would be reasonable to hypothesize that exercise in the afternoon may be best at combating natural declines in health as well as optimizing training adaptations. However, not all studies agree that afternoon is the best time to exercise. In fact, some have demonstrated that 12 wks of aerobic plus resistance exercise improved glycemic control whether performed in the morning or afternoon in adults with T2D. Moreover, consistent morning exercise has been suggested to improve exercise adherence through possible enjoyment as well as lead to greater weight loss. Taken together, additional work is warranted to understand time of day in which exercise is performed given circadian influence may contribute to variations in favorable metabolic as well as vascular adaptation for CVD prevention/treatment. Excitingly, we have preliminary data showing that afternoon exercise induces greater weight loss, reductions in food intake as well as perceptions of appetite and increased insulin sensitivity when compared to morning exercisers. Thus, the overall purpose of this proposal is to determine whether exercise time of day differentially enhances likelihood of weight loss via appetite regulation as well as glycemic control. Our overarching hypothesis is that afternoon exercise will enhance the effectiveness of exercise to induce weight loss, improve appetite and improve glycemic regulation compared to exercise in the morning. Taken together, findings from this study will inform public health recommendations to contemporary behavioral strategies to treat T2D. The study will also provide much needed experimental evidence to time of day in which exercise is performed influences public health risk.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
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
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
63 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
Exercise Morning
Arm Type
Experimental
Arm Description
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.
Arm Title
Exercise Afternoon
Arm Type
Active Comparator
Arm Description
If subjects are assigned to this group, they will participate in the same exercise program but after in the afternoon.
Intervention Type
Behavioral
Intervention Name(s)
Exercise Morning
Intervention Description
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.
Intervention Type
Behavioral
Intervention Name(s)
Exercise Afternoon
Intervention Description
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.
Primary Outcome Measure Information:
Title
Body Weight
Description
The primary outcome is changes in body weight pre- and post-intervention
Time Frame
Over the course of 2 weeks.
Secondary Outcome Measure Information:
Title
Glucose Tolerance
Description
We will examine the influence of Noom on the glucose area under the curve during the oral glucose tolerance test.
Time Frame
Over the course of 2 weeks.
Title
Flow-mediated dilation
Description
We will assess blood flow to better understand nutrient/glucose delivery.
Time Frame
Over the course of 2 weeks.
10. Eligibility
Sex
All
Minimum Age & Unit of Time
30 Years
Maximum Age & Unit of Time
70 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
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).
Exclusion Criteria:
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, benzephetamine, diethylpropion, phendimetrazine)
Known hypersensitivity to perflutren (contained in Definity)
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Steven K Malin
Phone
848-932-7054
Email
steven.malin@rutgers.edu
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Steven K Malin, PhD
Organizational Affiliation
Rutgers University - New Brunswick
Official's Role
Principal Investigator
Facility Information:
Facility Name
New Jersey Institute for Food, Nutrition, and Health
City
New Brunswick
State/Province
New Jersey
ZIP/Postal Code
08901
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Sue Shapses
Phone
848-932-9403
Email
shapses@rutgers.edu
Facility Name
Robert Wood Johnson University Hospital Clinical Research Center
City
New Brunswick
State/Province
New Jersey
ZIP/Postal Code
08901
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Deborah McCloskey
Phone
732-235-5965
Email
mcclosda@rwjms.rutgers.edu
Facility Name
Rutgers University Loree Gymnasium
City
New Brunswick
State/Province
New Jersey
ZIP/Postal Code
08901
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Steven K Malin
Phone
848-932-7540
Email
steven.malin@rutgers.edu
12. IPD Sharing Statement
Plan to Share IPD
No
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Exercise and Time of Day in Type 2 Diabetes
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