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NCT02169518: PON1

Paraoxonase and HDL Qualities in Glycaemia and Inflammation

Recruiting now Last updated 12 April 2023
What this trial tests

trial in Diabetes Mellitus in 600 participants. Currently enrolling.

Timeline
5 July 2012
Primary endpoint
31 January 2030
31 January 2030

Quick facts

Lead sponsorManchester University NHS Foundation Trust
StatusRecruiting now
Study typeOBSERVATIONAL
Enrollment600
Start date5 July 2012
Primary completion31 January 2030
Estimated completion31 January 2030
Sites1 location across United Kingdom

Conditions studied

Sponsor

Manchester University NHS Foundation Trust

Who can join

Adults 20 to 75, any sex, with Diabetes Mellitus or Bariatric Surgery Candidate. Patients with the condition only — healthy volunteers not accepted.

Sponsor's own description

The incidence of coronary heart disease (CHD) is significant in the super-obese and diabetics. Inflammation is believed to play an important part in the development of CHD, and the large collection of abdominal fat in the obese person is a vast source of inflammation. Diabetics have abnormal glucose and cholesterol metabolism which ultimately compromise their bodies' circulatory system and nerve function. Cholesterol plays a vital role in CHD. Low-density lipoprotein (LDL) particles carry cholesterol and deposit it in blood vessel walls which become damaged as a result. When LDL particles undergo changes chemically (called oxidation) or as a result of high circulating blood glucose (called glycation), they become more harmful to the body. High-density lipoprotein (HDL) particles have a protective function in CHD. Not only do they transport cholesterol away from the blood vessels to the liver to be broken down, they have properties against oxidation and inflammation. These properties are related to the activity of an enzyme on HDL called paraoxonase 1(PON1). Super-obese patients are increasingly treated by weight-reducing surgery (bariatric surgery). In this study we examine whether weight loss following bariatric surgery results in reduced inflammatory state, improved HDL function (higher PON1 activity), better control of blood glucose and less nerve damage. We will study PON1 activity, inflammation and glucose control in patients with type 1 diabetes (with and without kidney damage) and type 2 diabetes. We will also study the effects of rapidly rising blood glucose levels on PON1 and glycated LDL in patients undergoing oral glucose tolerance test.

Publications & conference data

1 peer-reviewed publication reference this trial (live from Europe PMC):

  1. Effect of Roux-en-Y Bariatric Surgery on Lipoproteins, Insulin Resistance, and Systemic and Vascular Inflammation in Obesity and Diabetes.
    Yadav R, Hama S, Liu Y, Siahmansur T, et al · · 2017 · cited 45× · PMID 29187850 · DOI 10.3389/fimmu.2017.01512

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Other recruiting trials for Diabetes Mellitus

Currently open trials in the same condition.

Other Manchester University NHS Foundation Trust trials

Trials by the same sponsor.

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Data sources for this page

Drug Landscape aggregates and links these public records for informational use only. Always verify against the primary source before clinical or regulatory decisions. Canonical URL: https://druglandscape.com/trial/NCT02169518.

Primary sources · FDA · ClinicalTrials.gov · EMA · SEC EDGAR · ChEMBL · Wikidata · full sourcing