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Clinical Trial NCT03883412 (ZQL007) for Type2 Diabetes is recruiting. See the Trial Radar Card View and AI discovery tools for all the details. Or ask anything here. | ||
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University of VirginiaEffect of Exercise and/or Liraglutide on Vascular Dysfunction and Insulin Sensitivity in Type 2 Diabetes ( ZQL007)
Clinical Trial NCT03883412 (ZQL007) is designed to study Treatment for Type2 Diabetes. It is a Phase 4 interventional trial that is recruiting, having started on 28 February 2019, with plans to enroll 60 participants. Led by University of Virginia, it is expected to complete by 1 December 2025. The latest data from ClinicalTrials.gov was last updated on 20 December 2023.
Brief Summary
The primary objective of this study is to examine whether exercise training alone, liraglutide treatment alone or exercise training plus liraglutide treatment increases cardiac and muscle capillary blood volume, improves vascular function in the larger conduit vessels, and enhances insulin's metabolic action in humans with Type 2 diabetes. Subjects will be randomized to one of the three groups: exercise training, liraglutide treatment, and exercise + liraglutide. They will be studied at the baseline and then after 16 weeks of intervention.
Detailed Description
Our hypothesis is that sustained activation of the GLP-1 receptor with Liraglutide or exercise training will enhance microvascular perfusion, promote angiogenesis, and improve microvascular response to insulin in muscle, leading to increased muscle delivery of oxygen and nutrients and increased exercise tolerance in subjects with type 2 diabetes.
Official Title
Effect of Exercise and/or Liraglutide on Vascular Dysfunction and Insulin Sensitivity in Type 2 Diabetes ( ZQL007)
Conditions
TYPE2 DiabetesPublications
Scientific articles and research papers published about this clinical trial:- Hamburg NM, Balady GJ. Exercise rehabilitation in peripheral artery disease: functional impact and mechanisms of benefits. Circulation. 2011 Jan 4;123(1):87-97. doi: 10.1161/CIRCULATIONAHA.109.881888. No abstract available.
- Honig CR, Odoroff CL, Frierson JL. Active and passive capillary control in red muscle at rest and in exercise. Am J Physiol. 1982 Aug;243(2):H196-206. doi: 10.1152/ajpheart.1982.243.2.H196.
- Barrett EJ, Eggleston EM, Inyard AC, Wang H, Li G, Chai W, Liu Z. The vascular actions of insulin control its delivery to muscle and regulate the rate-limiting step in skeletal muscle insulin action. Diabetologia. 2009 May;52(5):752-64. doi: 10.1007/s00125-009-1313-z. Epub 2009 Mar 13.
- Vincent MA, Clerk LH, Lindner JR, Klibanov AL, Clark MG, Rattigan S, Barrett EJ. Microvascular recruitment is an early insulin effect that regulates skeletal muscle glucose uptake in vivo. Diabetes. 2004 Jun;53(6):1418-23. doi: 10.2337/diabetes.53.6.1418.
- Eggleston EM, Jahn LA, Barrett EJ. Hyperinsulinemia rapidly increases human muscle microvascular perfusion but fails to increase muscle insulin clearance: evidence that a saturable process mediates muscle insulin uptake. Diabetes. 2007 Dec;56(12):2958-63. doi: 10.2337/db07-0670. Epub 2007 Aug 24.
- Chai W, Wang W, Liu J, Barrett EJ, Carey RM, Cao W, Liu Z. Angiotensin II type 1 and type 2 receptors regulate basal skeletal muscle microvascular volume and glucose use. Hypertension. 2010 Feb;55(2):523-30. doi: 10.1161/HYPERTENSIONAHA.109.145409. Epub 2009 Dec 7.
- Liu Z, Liu J, Jahn LA, Fowler DE, Barrett EJ. Infusing lipid raises plasma free fatty acids and induces insulin resistance in muscle microvasculature. J Clin Endocrinol Metab. 2009 Sep;94(9):3543-9. doi: 10.1210/jc.2009-0027. Epub 2009 Jun 30.
- Liu J, Jahn LA, Fowler DE, Barrett EJ, Cao W, Liu Z. Free fatty acids induce insulin resistance in both cardiac and skeletal muscle microvasculature in humans. J Clin Endocrinol Metab. 2011 Feb;96(2):438-46. doi: 10.1210/jc.2010-1174. Epub 2010 Nov 3.
- Vincent MA, Barrett EJ, Lindner JR, Clark MG, Rattigan S. Inhibiting NOS blocks microvascular recruitment and blunts muscle glucose uptake in response to insulin. Am J Physiol Endocrinol Metab. 2003 Jul;285(1):E123-9. doi: 10.1152/ajpendo.00021.2003.
- Jiang ZY, Lin YW, Clemont A, Feener EP, Hein KD, Igarashi M, Yamauchi T, White MF, King GL. Characterization of selective resistance to insulin signaling in the vasculature of obese Zucker (fa/fa) rats. J Clin Invest. 1999 Aug;104(4):447-57. doi: 10.1172/JCI5971.
- Kim JA, Koh KK, Quon MJ. The union of vascular and metabolic actions of insulin in sickness and in health. Arterioscler Thromb Vasc Biol. 2005 May;25(5):889-91. doi: 10.1161/01.ATV.0000164044.42910.6b. No abstract available.
- Kim JA, Montagnani M, Koh KK, Quon MJ. Reciprocal relationships between insulin resistance and endothelial dysfunction: molecular and pathophysiological mechanisms. Circulation. 2006 Apr 18;113(15):1888-904. doi: 10.1161/CIRCULATIONAHA.105.563213.
- Rattigan S, Clark MG, Barrett EJ. Acute vasoconstriction-induced insulin resistance in rat muscle in vivo. Diabetes. 1999 Mar;48(3):564-9. doi: 10.2337/diabetes.48.3.564.
- Youd JM, Rattigan S, Clark MG. Acute impairment of insulin-mediated capillary recruitment and glucose uptake in rat skeletal muscle in vivo by TNF-alpha. Diabetes. 2000 Nov;49(11):1904-9. doi: 10.2337/diabetes.49.11.1904.
- Clerk LH, Rattigan S, Clark MG. Lipid infusion impairs physiologic insulin-mediated capillary recruitment and muscle glucose uptake in vivo. Diabetes. 2002 Apr;51(4):1138-45. doi: 10.2337/diabetes.51.4.1138.
- Wallis MG, Wheatley CM, Rattigan S, Barrett EJ, Clark AD, Clark MG. Insulin-mediated hemodynamic changes are impaired in muscle of Zucker obese rats. Diabetes. 2002 Dec;51(12):3492-8. doi: 10.2337/diabetes.51.12.3492.
- Clerk LH, Vincent MA, Jahn LA, Liu Z, Lindner JR, Barrett EJ. Obesity blunts insulin-mediated microvascular recruitment in human forearm muscle. Diabetes. 2006 May;55(5):1436-42. doi: 10.2337/db05-1373.
- Chai W, Liu J, Jahn LA, Fowler DE, Barrett EJ, Liu Z. Salsalate attenuates free fatty acid-induced microvascular and metabolic insulin resistance in humans. Diabetes Care. 2011 Jul;34(7):1634-8. doi: 10.2337/dc10-2345. Epub 2011 May 26.
- Potenza MA, Marasciulo FL, Chieppa DM, Brigiani GS, Formoso G, Quon MJ, Montagnani M. Insulin resistance in spontaneously hypertensive rats is associated with endothelial dysfunction characterized by imbalance between NO and ET-1 production. Am J Physiol Heart Circ Physiol. 2005 Aug;289(2):H813-22. doi: 10.1152/ajpheart.00092.2005. Epub 2005 Mar 25.
- Eringa EC, Stehouwer CD, Merlijn T, Westerhof N, Sipkema P. Physiological concentrations of insulin induce endothelin-mediated vasoconstriction during inhibition of NOS or PI3-kinase in skeletal muscle arterioles. Cardiovasc Res. 2002 Dec;56(3):464-71. doi: 10.1016/s0008-6363(02)00593-x.
Other Study IDs
- ZQL007
- 20320
NCT ID Number
Start Date (Actual)
2019-02-28
Last Update Posted
2023-12-20
Completion Date (Estimated)
2025-12
Enrollment (Estimated)
60
Study Type
Interventional
PHASE
Phase 4
Status
Recruiting
Primary Purpose
Treatment
Design Allocation
Randomized
Interventional Model
Factorial
Masking
None (Open Label)
Arms / Interventions
| Participant Group/Arm | Intervention/Treatment |
|---|---|
ExperimentalExercise Alone 16 weeks of treatment | Exercise 16 weeks of treatment |
ExperimentalLiraglutide alone 16 weeks of treatment | Liraglutide 16 weeks of Liraglutide |
ExperimentalExercise + Liraglutide 16 weeks of treatment | Exercise 16 weeks of treatment Liraglutide 16 weeks of Liraglutide |
Primary Outcome Measures
Secondary Outcome Measures
| Outcome Measure | Measure Description | Time Frame |
|---|---|---|
Microvascular Blood Volume - change from baseline | measured at baseline and 16 weeks | 16 weeks |
| Outcome Measure | Measure Description | Time Frame |
|---|---|---|
Augmentation Index - change from baseline | measured at baseline and 16 weeks | 16 weeks |
Flow Mediated Dilation - change from baseline | measured at baseline and 16 weeks | 16 weeks |
Pulse Wave Velocity - change from baseline | measured at baseline and 16 weeks | 16 weeks |
Post Ischemic Flow Velocity-Change from baseline | measured at baseline and 16 weeks | 16 weeks |
Insulin Sensitivity-Change from baseline | measured at baseline and 16 weeks | 16 weeks |
Eligibility Criteria
Eligible Ages
Adult
Minimum Age
21 Years
Eligible Sexes
All
Accepts Healthy Volunteers
Yes
- Age 21-60
- A1C ≤ 8.5%
- Never on GLP-1RA (eg: exenatide, liraglutide) or DPP4I ( eg: Sitaglipton)
- On stable dose of oral hypoglycemic agents >4 months
- On stable dose of other medications for >4 months
- Taking Insulin
- Smoking presently or in the past 6 months
- BP >160/90
- BMI >35
- Family history of medullary thyroid cancer or multiple endocrine neoplasia syndrome
- History of congestive heart failure, ischemic heart disease, severe pulmonary disease, liver or kidney disease.
- Any vascular disease such as myocardial infarction, stroke, peripheral vascular disease
- Presence of an intracardiac or intrapulmonary shunt (we will screen for this by auscultation during the physical exam by PI).
- Pregnant or breastfeeding.
- Known hypersensitivity to perflutren (contained in Definity)
University of Virginia- American Diabetes Association
- National Institutes of Health (NIH)
Study Responsible Party
Zhenqi Liu, Principal Investigator, Professor and Chief, Division of Endocrinology and Metabolism, University of Virginia
Study Central Contact
Contact: Lee Hartline, MEd, 434-924-5247, [email protected]
Contact: Linda Jahn, RN, MEd, 434-924-1134, [email protected]
1 Study Locations in 1 Countries
Virginia
University of Virginia, Charlottesville, Virginia, 22906, United States
Zhenqi Liu, MD, Contact, 434-243-2603, [email protected]
Eugene Barrett, MD, PhD, Contact, 434-924-1175, [email protected]
Recruiting