Actively Recruiting

Age: 20Years - 75Years
All Genders
Healthy Volunteers
NCT02169518

Paraoxonase and HDL Qualities in Glycaemia and Inflammation

Led by Manchester University NHS Foundation Trust · Updated on 2023-04-12

600

Participants Needed

1

Research Sites

917 weeks

Total Duration

On this page

Sponsors

M

Manchester University NHS Foundation Trust

Lead Sponsor

B

British Heart Foundation

Collaborating Sponsor

AI-Summary

What this Trial Is About

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.

CONDITIONS

Official Title

Paraoxonase and HDL Qualities in Glycaemia and Inflammation

Who Can Participate

Age: 20Years - 75Years
All Genders
Healthy Volunteers

Eligibility Criteria

Eligible

You may qualify if you...

  • Patients with type 1 diabetes not taking lipid-lowering drugs, omega fatty acid supplements, or thiazolidinediones and without signs of coronary heart disease (CHD).
  • Patients with type 2 diabetes not taking omega fatty acid supplements or thiazolidinediones and without signs of CHD.
  • Patients with impaired fasting glucose undergoing oral glucose tolerance test.
  • Patients scheduled for bariatric surgery.
  • Healthy controls without major acute or chronic illness, not on regular medication, not taking omega fatty acid supplements, and without overt ischaemic heart disease.
  • Both male and female participants aged 20 to 75 years.
  • Participants capable of giving informed consent.
Not Eligible

You will not qualify if you...

  • Type 1 diabetics using lipid-lowering therapy, thiazolidinediones, or omega fatty acid supplements.
  • Type 1 diabetics with history or ECG evidence of coronary heart disease (CHD).
  • Type 2 diabetics receiving thiazolidinediones or omega fatty acid supplements.
  • Type 2 diabetics with history or ECG evidence of CHD.
  • Healthy controls with any history of CHD, vascular insufficiency, or diabetes.
  • Use of any lipid-lowering drugs or omega fatty acid supplements by healthy controls.

AI-Screening

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Trial Site Locations

Total: 1 location

1

Central Manchester University Hospitals NHS Foundatioon Trust

Manchester, Lancashire, United Kingdom, M13 9WL

Actively Recruiting

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Research Team

H

Handrean Soran, MD FRCP

CONTACT

S

See Kwok, MD FRCGP

CONTACT

How is the study designed?

Study Type

OBSERVATIONAL

Masking

N/A

Allocation

N/A

Model

N/A

Primary Purpose

N/A

Number of Arms

2

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