RecruitingOBSERVATIONAL

Paraoxonase and HDL Qualities in Glycaemia and Inflammation

This study investigates the link between obesity, diabetes, and heart disease. Specifically, we're looking at how 'good' cholesterol, called HDL, functions to protect your heart. HDL normally helps remove harmful fats and fights inflammation. We believe a certain enzyme on HDL, called PON1, is key to its protective qualities. We will study people with type 1 and type 2 diabetes, as well as those considering weight-loss surgery. Our aim is to see if weight loss surgery improves inflammation and HDL function, and how blood sugar levels affect HDL and other fats in the blood. Understanding these changes could help us find better ways to reduce heart disease risk in these groups.

At a glance

Status

Recruiting

Sponsor

Manchester University NHS Foundation Trust

Enrolment target

600

Start

05 Jul 2012

Estimated completion

31 Jan 2030

Diabetes Mellitus Bariatric Surgery Candidate

What is this study about?

Heart disease is a significant concern for people who are very overweight (sometimes called super-obese) and those with diabetes. Many believe that ongoing inflammation in the body plays a big part in heart disease. For example, a lot of extra fat around the tummy in obese individuals can create a large amount of inflammation. People with diabetes also have issues with how their bodies handle sugar and fats, which can eventually damage their blood vessels and nerves.

Cholesterol is often talked about in relation to heart issues. There are 'bad' types of cholesterol (LDL) that can build up in blood vessel walls, causing damage. When these 'bad' cholesterol particles are changed by sugar or other chemicals in the body, they become even more harmful. On the other hand, 'good' cholesterol (HDL) is protective. It helps remove excess cholesterol from your blood vessels and carries it back to the liver to be processed. HDL also has properties that fight against inflammation and harmful chemical changes. These protective qualities are linked to a specific enzyme on HDL called paraoxonase 1 (PON1).

This study aims to understand how weight-loss surgery affects inflammation, the protective function of HDL (specifically, its PON1 activity), and blood sugar control in people who are very overweight. We also want to explore how PON1 activity and inflammation are affected in people with type 1 and type 2 diabetes. By understanding these connections, we hope to learn more about how we can better protect people from heart disease.

Key takeaways

The study explores how 'good' cholesterol (HDL) protects the heart.
It investigates the role of a special enzyme, PON1, on HDL.
Researchers are looking at how diabetes and weight loss surgery affect HDL function, inflammation, and blood sugar.
The aim is to understand these factors to potentially reduce the risk of heart disease.
It includes people with Type 1 and Type 2 diabetes, those having weight loss surgery, and healthy volunteers.

Who may be eligible?

To be considered for this study, you would generally need to be between 20 and 75 years old. We are looking for people with Type 1 diabetes, Type 2 diabetes, or individuals who are planning to have weight-loss (bariatric) surgery. We are also including healthy volunteers to compare results.

There are some specific requirements: if you have diabetes, you shouldn't be taking certain medications like 'lipid-lowering drugs' (for cholesterol), 'omega fatty acid supplements', or certain diabetes medications called 'thiazolidinediones'. You also shouldn't have any signs of existing heart disease from medical tests or your history.

We would not be able to include you if you have a history of heart disease, blood circulation problems, or if you are taking any of the excluded medications mentioned above for either diabetes or high cholesterol. Healthy volunteers should also not have any serious illnesses or be on regular medication.

Could this study suit you?

Answer these quick questions to see if you may be eligible. This is a guide only — the research team makes the final call.

Are you between 20 and 75 years old?
Do you have Type 1 or Type 2 diabetes, or are you scheduled for weight-loss surgery?
Are you NOT taking specific cholesterol-lowering drugs, omega-3 supplements, or certain diabetes medications?
Do you have no known history or signs of existing heart disease (from medical records or ECGs)?
If you are a healthy volunteer, do you have no major existing health conditions or take regular medication?

Answer every question to see your result.

What does participation involve?

This section of the study information is not available in the brief summary. More detailed information would be provided by the research team if you were to participate. Typically, this type of study may involve clinic visits for blood tests, possibly a glucose tolerance test (where you drink a sugary drink and have blood samples taken over a few hours), and assessments before and after any planned bariatric surgery. The total duration of participation would depend on whether you are undergoing surgery or participating as a diabetic or healthy control, and this would be explained in full detail by the study team.

Potential risks and benefits

Participating in this study might help us gain a better understanding of how diabetes, obesity, and weight loss surgery affect heart health. This could lead to improved treatments in the future. Potential risks are generally low, mainly related to blood draws, which can cause minor bruising or discomfort. Any procedures and their associated risks would be fully explained before you consent to take part. You are free to withdraw from the study at any time without giving a reason, and your medical care will not be affected.

Locations (1)

Some site locations are approximate. We're improving this — please verify with the trial team before travelling.

Central Manchester University Hospitals NHS Foundatioon Trust
Verified postcode
Manchester, United Kingdom· Recruiting

Common questions

What is 'good' cholesterol (HDL) and 'bad' cholesterol (LDL)?

HDL is often called 'good' cholesterol because it helps remove excess cholesterol from your blood vessels. LDL is known as 'bad' cholesterol because it can build up in your arteries, leading to problems.

What is PON1?

PON1 is an enzyme found on your 'good' cholesterol (HDL) that plays a key role in protecting your blood vessels from damage and inflammation.

What is bariatric surgery?

Bariatric surgery is a type of weight-loss surgery for people with severe obesity, where changes are made to the digestive system to help reduce food intake and absorption.

Why is inflammation important in heart disease?

Ongoing inflammation in your body can damage blood vessels and contribute to the development and progression of heart disease.

What is an oral glucose tolerance test?

This is a test where you drink a sugary liquid, and then blood samples are taken over a couple of hours to see how your body handles sugar.

How to find out more

Handrean Soran, MD FRCP

hsoran@aol.com 01612764843 Official trial record

Always speak to your GP or specialist before deciding to take part in a study.