The effect of variation of fatty substances found in the blood on patients with type 2 diabetes. ISRCTN27314990

Sathyapalan, Thozhukat

Abstract

Background and study aims
High blood sugar and fat content are well-recognised risk factors for causing the formation of obstructive plaques in arteries which lead to cardiovascular disease, for example heart attacks. From earlier studies, we know that after eating, high sugar and fat content in the blood seems to have an association with cardiovascular risk in both healthy persons and individuals with type 2 diabetes. This study aims to examine the effect on the body of variation of fat levels in the blood compared to constant fat levels, during a constant high sugar state.

Who can participate?
This study is open to individuals with type 2 diabetes and non-diabetic individuals between the ages of 30 - 65 years with a body mass index between 27 - 40 kg/m² (overweight or obese).

What does the study involve?
This study includes one screening visit and two procedural visits during which participants will have sugar infused into their blood. Blood will be drawn at various time points during the procedure for analysis. Participants will be closely monitored by trained medical and nursing staff throughout the procedure. There will be one week break between visit 2 and visit 3 to prevent the carried over effects of infusions. We expect individual participants would be in the study for 3-4 weeks in total.

What are the possible benefits and risks of participating?
Benefits: No immediate benefits, however, the knowledge gained in the study will help the management of diabetes in the future.
Risks: Potential for a reaction to the fatty substance given by the drip and discomfort from the cannula (plastic needle). A fully advanced life support trained research doctor will be present at all times to manage any emergency situation that arises however this is a rare occurrence. All the potential risks will be fully disclosed and discussed with potential participants at screening before he/she consents to take part in the study.

Where is the study run from?
University of Hull (UK)

When is the study starting and how long is it expected to run for?
June 2014 to October 2021

Who is funding the study?
University of Hull (UK)

Citation

Sathyapalan, T. (2020). The effect of variation of fatty substances found in the blood on patients with type 2 diabetes. ISRCTN27314990

• Other Type: Protocol
• Online Publication Date: Nov 9, 2020
• Publication Date: 2020
• Deposit Date: May 15, 2021
• Publicly Available Date: Aug 28, 2024
• Publisher: Springer (part of Springer Nature)
• DOI: https://doi.org/10.1186/isrctn27314990
• Public URL: https://hull-repository.worktribe.com/output/3661415
• Publisher URL: https://www.isrctn.com/ISRCTN27314990