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IMST for Type 2 Diabetes (DIT Trial)

N/A
Recruiting
Led By Dallin Tavoian, PhD
Research Sponsored by University of Arizona
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
Diagnosed with type 2 diabetes by physician
Be older than 18 years old
Timeline
Screening 3 weeks
Treatment Varies
Follow Up blood plasma collected and analyzed at baseline and after 6 weeks of training
Awards & highlights

DIT Trial Summary

This trial will look at how 6 weeks of breathing exercises can improve health outcomes in adults with Type 2 Diabetes.

Who is the study for?
Adults recently diagnosed with type 2 diabetes who have high blood pressure (120-169 mmHg systolic), stable weight, and medication doses. They must not have unstable diseases, severe respiratory conditions, ear problems, asthma, be pregnant or smoking. Regular exercisers and those with extreme obesity or recent heart attacks are excluded.Check my eligibility
What is being tested?
The trial is testing the effects of a breathing exercise called Inspiratory Muscle Strength Training (IMST) on metabolism and heart health in adults with new-onset type 2 diabetes over six weeks.See study design
What are the potential side effects?
While specific side effects aren't listed for IMST, potential risks may include discomfort from the training device or fatigue from the exercises.

DIT Trial Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below
Select...
I have been diagnosed with type 2 diabetes by a doctor.

DIT Trial Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~blood pressure will be assessed at baseline and after 6 weeks of training
This trial's timeline: 3 weeks for screening, Varies for treatment, and blood pressure will be assessed at baseline and after 6 weeks of training for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.
Primary outcome measures
Change from baseline fasting blood plasma Insulin after 6 weeks of IMST
Change from baseline fasting blood plasma glucose after 6 weeks of IMST
Change from baseline insulin sensitivity after 6 weeks of IMST
Secondary outcome measures
Change from baseline Nitric Oxide-mediated Endothelial Dependent Dilation (EDD)
Change from baseline systolic blood pressure after 6 weeks of IMST
Other outcome measures
Change from baseline proteomic analysis

DIT Trial Design

2Treatment groups
Experimental Treatment
Active Control
Group I: High-resistance IMSTExperimental Treatment1 Intervention
30 breaths/day (5 sets of 6 breaths, one minute of rest between sets), 5 days/week, 6 weeks
Group II: Low-resistance IMSTActive Control1 Intervention
30 breaths/day (5 sets of 6 breaths, one minute of rest between sets), 5 days/week, 6 weeks

Find a Location

Who is running the clinical trial?

University of ArizonaLead Sponsor
515 Previous Clinical Trials
148,684 Total Patients Enrolled
Dallin Tavoian, PhDPrincipal InvestigatorUniversity of Arizona
1 Previous Clinical Trials
36 Total Patients Enrolled

Media Library

Inspiratory Muscle Strength Training Clinical Trial Eligibility Overview. Trial Name: NCT05643768 — N/A
High Blood Pressure Research Study Groups: High-resistance IMST, Low-resistance IMST
High Blood Pressure Clinical Trial 2023: Inspiratory Muscle Strength Training Highlights & Side Effects. Trial Name: NCT05643768 — N/A
Inspiratory Muscle Strength Training 2023 Treatment Timeline for Medical Study. Trial Name: NCT05643768 — N/A

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

Is the age criterion for participants in this trial limited to those under 25?

"As per the stated rules of this medical trial, individuals must be between 18 and 65 years old in order to qualify for inclusion."

Answered by AI

Are there still opportunities for those interested in participating to join the experiment?

"According to information posted on clinicaltrials.gov, this research is no longer recruiting patients; the protocol was initially published on January 15th 2023 and last updated November 30th 2022. Nevertheless, there are 2191 other studies that are actively searching for participants as of now."

Answered by AI

Are there any restrictions on who can join this clinical trial?

"This study is looking to enrol 30 people aged between 18 and 65 that have been newly diagnosed with type 2 diabetes. Other eligibility requirements include a fasting plasma glucose level of over 126 mg/dl, no current use of diabetic medication, systolic blood pressure between 120-169 mmHg, and abstention from medications for hypertension."

Answered by AI

Who else is applying?

What site did they apply to?
Arizona Respiratory and Neurophysiology Laboratory
What portion of applicants met pre-screening criteria?
Did not meet criteria
~5 spots leftby Jun 2024