Examining HDL and inflammation in diabetes and obesity
Changes in Paraoxonase Activity, HDL Properties, Inflammatory Markers and Corneal Innervation in Post-bariatric Surgery Patients, Type 1 Diabetics With and Without Nephropathy, Type 2 Diabetics, and During an Oral Glucose Tolerance Test.
This study looks at how HDL cholesterol and inflammation affect heart health in people with diabetes and obesity who are having weight loss surgery.
Quick facts
| Study type | Observational |
|---|---|
| Enrollment | 600 (estimated) |
| Ages | 20 Years to 75 Years |
| Sex | All |
| Sponsor | Manchester University NHS Foundation Trust Government |
| Locations | 1 site (Manchester, Lancashire) |
| Trial ID | NCT02169518 on ClinicalTrials.gov |
What this trial studies
This observational study investigates the role of high-density lipoprotein (HDL) and its enzyme paraoxonase 1 (PON1) in patients with diabetes and obesity, particularly those scheduled for bariatric surgery. It aims to understand how inflammation and visceral fat affect HDL functionality and PON1 activity, which are crucial for cardiovascular health. The study will assess patients before and after bariatric surgery to evaluate changes in HDL properties and related physiological parameters. By focusing on both Type 1 and Type 2 diabetes patients, the research seeks to uncover potential links between weight loss and improvements in cardiovascular risk factors.
Who should consider this trial
Good fit: Ideal candidates include adults aged 20 to 75 with Type 1 or Type 2 diabetes who are scheduled for bariatric surgery and meet specific inclusion criteria.
Not a fit: Patients currently on lipid-lowering therapy or those with existing coronary heart disease may not benefit from this study.
Why it matters
Potential benefit: If successful, this study could lead to improved cardiovascular health outcomes for obese patients with diabetes by enhancing our understanding of HDL functionality.
How similar studies have performed: While the specific approach of this study is novel, previous research has indicated the importance of HDL and inflammation in cardiovascular disease, suggesting potential for meaningful insights.
Eligibility criteria
Show full inclusion / exclusion criteria
Inclusion Criteria: * 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. Type 2 diabetic patients who are not receiving omega fatty acid supplements or thiazolidinediones and without clinical and/or ECG evidence of CHD. Patients with impaired fasting glucose undergoing oral glucose tolerance test. Patients scheduled for bariatric surgery. Healthy controls who have no major acute or chronic illness, are not receiving regular medication and not taking omega fatty acid supplements, do not have clinically overt ischaemic heart disease. Subjects (male and female) aged between 20 and 75. Subjects who have capacity and understanding for informed consent process. Exclusion Criteria: * Type 1 diabetics using lipid lowering therapy, thiazolidinediones, omega fatty acid supplements. History and/or ECG evidence of ST segment changes indicative of CHD. Type 2 diabetics receiving thiazolidinediones, omega fatty acid supplements. History and/or ECG evidence of ST segment changes indicative of CHD. Healthy controls who have any history of CHD, vascular insufficiency, or diabetes. Use of any lipid-lowering drug or omega fatty acid supplements.
Where this trial is running
Manchester, Lancashire
- Central Manchester University Hospitals NHS Foundatioon Trust — Manchester, Lancashire, United Kingdom (Recruiting)
Study contacts
- Principal investigator: Handrean Soran, MD FRCP — Manchester University NHS Foundation Trust
- Study coordinator: Handrean Soran, MD FRCP
- Email: hsoran@aol.com
- Phone: 01612764843
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.