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Exercise Timing for Type 2 Diabetes
N/A
Recruiting
Led By Steven K Malin, PhD
Research Sponsored by Rutgers, The State University of New Jersey
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial Must have
Subjects currently taking medications that affect heart rate and rhythm (i.e. Ca++ channel blockers, nitrates, alpha- or beta-blockers)
Male or female >30 and <70 years old
Must not have
Evidence of type 1 diabetes and diabetics requiring insulin therapy
Currently taking active weight suppression medication (e.g. phentermine,orlistat, lorcaserin, naltrexone-bupropion in combination, liraglutide, benzephetamine, diethylpropion, phendimetrazine)
Timeline
Screening 3 weeks
Treatment Varies
Follow Up over the course of 2 weeks.
Awards & highlights
No Placebo-Only Group
Summary
This trial will test whether Noom, a weight-loss app, helps people with type 2 diabetes better stick to their exercise and diet plan, leading to more weight loss and better health.
Who is the study for?
Adults aged 30-70 with type 2 diabetes, a BMI between 28 and 45, not currently on weight loss meds or insulin therapy. Mustn't have significant heart, liver, kidney diseases or cancer. Non-smokers only (or those who quit over a year ago), not pregnant/nursing, and haven't been exercising regularly.
What is being tested?
The trial is testing the effectiveness of Noom for improving diet adherence during exercise in the morning vs. afternoon for better weight loss and heart health in type 2 diabetics. It's checking if this leads to better blood sugar control and blood pressure.
What are the potential side effects?
Since this study involves lifestyle changes rather than medication, side effects may include typical exercise-related issues such as muscle soreness or fatigue but are generally minimal compared to drug interventions.
Eligibility Criteria
Inclusion Criteria
You may be eligible if you check “Yes” for the criteria belowSelect...
I am currently on medication that affects my heart rate or rhythm.
Select...
I am between 30 and 70 years old.
Select...
I have been diagnosed with type 2 diabetes.
Exclusion Criteria
You may be eligible for the trial if you check “No” for criteria below:Select...
I have type 1 diabetes and need insulin.
Select...
I am currently on medication to help with weight loss.
Select...
I am currently smoking or quit less than a year ago.
Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ over the course of 2 weeks.
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~over the course of 2 weeks.
Treatment Details
Study Objectives
Study objectives can provide a clearer picture of what you can expect from a treatment.Primary study objectives
Body Weight
Secondary study objectives
Flow-mediated dilation
Glucose Tolerance
Awards & Highlights
No Placebo-Only Group
All patients enrolled in this study will receive some form of active treatment.
Trial Design
2Treatment groups
Experimental Treatment
Active Control
Group I: Exercise MorningExperimental Treatment2 Interventions
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.
Group II: Exercise AfternoonActive Control1 Intervention
If subjects are assigned to this group, they will participate in the same exercise program but after in the afternoon.
Find a Location
Who is running the clinical trial?
Rutgers, The State University of New JerseyLead Sponsor
455 Previous Clinical Trials
69,921 Total Patients Enrolled
4 Trials studying Metabolic Syndrome
597 Patients Enrolled for Metabolic Syndrome
Noom Inc.Industry Sponsor
16 Previous Clinical Trials
2,810 Total Patients Enrolled
Steven K Malin, PhDPrincipal InvestigatorRutgers University - New Brunswick
4 Previous Clinical Trials
252 Total Patients Enrolled
2 Trials studying Metabolic Syndrome
152 Patients Enrolled for Metabolic Syndrome
Media Library
Eligibility Criteria:
This trial includes the following eligibility criteria:- I have type 1 diabetes and need insulin.You are allergic to perflutren, which is in the study drug Definity.My BMI is either above 46 or below 27.I am currently on medication that affects my heart rate or rhythm.I am between 30 and 70 years old.You have an unusual kidney function test result.You have health reasons that make it unsafe for you to participate in an exercise training program.You have very high levels of triglycerides (over 400 mg/dl) and cholesterol (over 260 mg/dl).You have been doing intense exercise more than twice a week in the past month.I am currently on medication to help with weight loss.I have been diagnosed with type 2 diabetes.Your body mass index is between 28 and 45.You have a history of serious health problems that could affect the study results or your safety, according to the doctor.I am currently smoking or quit less than a year ago.Your weight has changed by more than 2 kilograms in the past 3 months.Your blood pressure is very high, above 160/100 mmHg.
Research Study Groups:
This trial has the following groups:- Group 1: Exercise Morning
- Group 2: Exercise Afternoon
Awards:
This trial has 1 awards, including:- No Placebo-Only Group - All patients enrolled in this study will receive some form of active treatment.
Timeline:
This trial has the following timeline:- Screening: It may take up to 3 Weeks to process to see if you qualify in this trial.
- Treatment: The duration you will receive the treatment varies.
- Follow Ups: You may be asked to continue sharing information regarding the trial for 6 Months after you stop receiving the treatment.