Paraoxonase and HDL Qualities in Glycaemia and Inflammation

Trial statusRecruiting
Trial phaseNot listed
Trial typeObservational
Biological sexAll
Age20-75
SponsorManchester University NHS Foundation Trust

About this trial

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.

Eligibility criteria

Qualifiers

Patients with Type 1 diabetes who are not receiving lipid-lowering drugs, omega fatty acid supplements or thiazolidinediones and without clinical and/or ECG evidence of CHD.

Disqualifiers

Type 1 diabetics using lipid lowering therapy, thiazolidinediones, omega fatty acid supplements. History and/or ECG evidence of ST segment changes indicative of CHD.

Trial design

Treatments tested in this trial

  • Not listed

Trial groups

600 Participants
are grouped into 2 trial groups

Sponsors and collaborators

Manchester University NHS Foundation Trust

Lead sponsor

British Heart Foundation

Collaborator

Juvenile Diabetes Research Foundation

Collaborator