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Exercise + Liraglutide for Type 2 Diabetes (ZQL007 Trial)

Phase 4

Recruiting

Led By Zhenqi Liu, MD

Research Sponsored by University of Virginia

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

Age 21-60

Never on GLP-1RA (eg: exenatide, liraglutide) or DPP4I (eg: Sitaglipton)

Timeline

Screening 3 weeks

Treatment Varies

Follow Up 16 weeks

Awards & highlights

ZQL007 Trial Summary

This trial is testing whether exercise, liraglutide, or a combination of the two can improve cardiac and muscle function in people with type 2 diabetes.

Who is the study for?

This trial is for adults aged 21-60 with Type 2 diabetes who have an A1C level of ≤8.5% and haven't used GLP-1RA or DPP4I medications. Participants should be on a stable dose of oral diabetes drugs for over four months, not taking insulin, non-smokers, with controlled blood pressure and BMI under 35. They must not have certain heart, lung, liver or kidney diseases, specific family cancer histories, vascular diseases or be pregnant.Check my eligibility

What is being tested?

The study aims to see if exercise alone, the drug Liraglutide alone, or both combined can improve blood vessel function and insulin sensitivity in people with Type 2 diabetes. Participants will be randomly assigned to one of three groups and evaluated before and after the 16-week intervention period.See study design

What are the potential side effects?

Liraglutide may cause nausea, diarrhea, vomiting; rare cases include pancreatitis or allergic reactions. Exercise is generally safe but could lead to muscle strain or injury especially if done improperly.

ZQL007 Trial Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below

Select...

I am between 21 and 60 years old.

Select...

I have never taken GLP-1RA or DPP4I medications.

ZQL007 Trial Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ 16 weeks

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~16 weeks

This trial's timeline: 3 weeks for screening, Varies for treatment, and 16 weeks for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.

Primary outcome measures

Microvascular Blood Volume - change from baseline

Secondary outcome measures

Augmentation Index - change from baseline

Flow Mediated Dilation - change from baseline

Insulin Sensitivity-Change from baseline

+2 more

Side effects data

From 2017 Phase 4 trial • 100 Patients • NCT02014740

29%

nausea

100%

80%

60%

40%

20%

Study treatment Arm

Liraglutide

Metformin

ZQL007 Trial Design

3Treatment groups

Experimental Treatment

Group I: Liraglutide aloneExperimental Treatment1 Intervention

16 weeks of treatment

Group II: Exercise AloneExperimental Treatment1 Intervention

16 weeks of treatment

Group III: Exercise + LiraglutideExperimental Treatment2 Interventions

16 weeks of treatment

Treatment

First Studied

Drug Approval Stage

How many patients have taken this drug

Liraglutide

2013

Completed Phase 4

~2680

0 / 2Eligibility criteria met

Find a Location

Who is running the clinical trial?

University of VirginiaLead Sponsor

754 Previous Clinical Trials

1,245,013 Total Patients Enrolled

American Diabetes AssociationOTHER

139 Previous Clinical Trials

99,546 Total Patients Enrolled

National Institutes of Health (NIH)NIH

2,701 Previous Clinical Trials

7,506,816 Total Patients Enrolled

Media Library

Exercise Clinical Trial Eligibility Overview. Trial Name: NCT03883412 — Phase 4

Type 2 Diabetes Research Study Groups: Exercise + Liraglutide, Liraglutide alone, Exercise Alone

Type 2 Diabetes Clinical Trial 2023: Exercise Highlights & Side Effects. Trial Name: NCT03883412 — Phase 4

Exercise 2023 Treatment Timeline for Medical Study. Trial Name: NCT03883412 — Phase 4

Frequently Asked Questions

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

How many participants is the clinical trial currently recruiting?

"Affirmative, the clinicaltrials.gov website attests that this examination is currently recruiting participants. This investigation, which was initially published on February 28th 2019, necessitates 60 patients from a solitary medical centre for completion."

Answered by AI

To what extent could Liraglutide have deleterious effects on an individual's wellbeing?

"Liraglutide has already been approved for medical use, which led our team at Power to rate its safety a 3 on the scale of 1-3."

Answered by AI

To what maladies has Liraglutide been linked as a potential curative agent?

"Liraglutide is often prescribed as part of a tailored exercise program. Additionally, it can be employed to manage inadequacies that arise from monotherapy, reduce cardiovascular risk and even treat specific cases of cardiovascular disease (CVD)."

Answered by AI

Is eligibility for this clinical experiment restricted to individuals below a certain age?

"The age of eligibility for this trial is set between 21 and 60 years old."

Answered by AI

What type of participant is the ideal candidate for this trial?

"This medical trial is recruiting 60 individuals between 21 and 60 who have type 2 diabetes. The applicability criteria include: being within the age range, having an A1C of 8.5% or lower, never using GLP-1RA such as exenatide or liraglutide, staying on a stead dose of oral hypoglycemic agents for over 4 monthsm and maintaining similar parameters with other medications for at least that period too."

Answered by AI

Are new participants being welcomed into this experimental program?

"Per the clinicaltrials.gov website, this clinical trial is currently in need of participants. It was initially listed on February 28th 2019 and last modified March 7th 2022."

Answered by AI

Recent research and studies

Journal of Clinical InvestigationJournal

Skeletal Muscle Capillary Density and Fiber Type Are Possible Determinants of in Vivo Insulin Resistance in Man.

Lillioja, S, A A Young, C L Culter, J L Ivy, W G Abbott, J K Zawadzki, H Yki-Järvinen, L Christin, T W Secomb, and C Bogardus. 1987. “Skeletal Muscle Capillary Density and Fiber Type Are Possible Determinants of in Vivo Insulin Resistance in Man.”. Journal of Clinical Investigation. American Society for Clinical Investigation. doi:10.1172/jci113088.

DiabetesJournal

Muscle-specific Vascular Endothelial Growth Factor Deletion Induces Muscle Capillary Rarefaction Creating Muscle Insulin Resistance

Bonner, Jeffrey S., Louise Lantier, Clinton M. Hasenour, Freyja D. James, Deanna P. Bracy, and David H. Wasserman. 2013. “Muscle-specific Vascular Endothelial Growth Factor Deletion Induces Muscle Capillary Rarefaction Creating Muscle Insulin Resistance”. Diabetes. American Diabetes Association. doi:10.2337/db12-0354.

DiabetesJournal

Insulin-mediated Hemodynamic Changes Are Impaired in Muscle of Zucker Obese Rats

Wallis, Michelle G., Catherine M. Wheatley, Stephen Rattigan, Eugene J. Barrett, Andrew D.H. Clark, and Michael G. Clark. 2002. “Insulin-mediated Hemodynamic Changes Are Impaired in Muscle of Zucker Obese Rats”. Diabetes. American Diabetes Association. doi:10.2337/diabetes.51.12.3492.

The Journal of PhysiologyJournal