Active not recruitingNAINTERVENTIONAL

Identification of New Biomarkers of Insulin Resistance

This research aims to find new early signs of insulin resistance, a condition that can lead to type 2 diabetes. Around 415 million people worldwide have diabetes, and most cases are type 2, often linked to weight and lifestyle. Insulin usually helps sugar enter muscles and fat, but in insulin resistance, this process doesn't work well. We're studying a protein called Rab3, which seems to play a role in this. We believe a certain diet and exercise plan can improve insulin resistance and in turn, increase Rab3 levels. We will measure Rab3 and also look at changes in gut bacteria, as they might affect insulin sensitivity. Understanding these changes could lead to better ways to prevent type 2 diabetes.

At a glance

Status

Active not recruiting

Phase

Sponsor

University of Bath

Enrolment target

Start

01 Feb 2018

Estimated completion

01 Jan 2028

Insulin Resistance Diabetes Mellitus, Type 2 Inflammation Gastrointestinal Microbiome

What is this study about?

Diabetes is a common health problem where your body struggles to control blood sugar. Type 2 diabetes is the most common kind, and it often develops when your body doesn't respond well to a hormone called insulin. This early stage, where insulin isn't working as it should, is called insulin resistance. If we can understand insulin resistance better, we might be able to find new ways to prevent type 2 diabetes from developing.

Our bodies usually use insulin to move sugar from our blood into our muscles and fat for energy. But in insulin resistance, this system doesn’t work properly, causing blood sugar levels to rise. We're particularly interested in a small protein called Rab3, which helps with this process. Previous research has shown that Rab3 levels can be lower in people with insulin resistance. This study will explore if Rab3 levels change after a special three-week diet and exercise plan designed to improve insulin sensitivity. We'll take samples from fat and muscle before and after this plan to see if Rab3 levels go up as insulin sensitivity improves.

We also know that the bacteria in your gut, called the gut microbiome, might play a role in how your body uses insulin. So, we'll also be looking at changes in these gut bacteria through stool samples before and after the diet and exercise plan. By studying Rab3 and the gut microbiome together, we hope to gain a clearer picture of what causes insulin resistance and how we might be able to help people avoid developing type 2 diabetes.

Key takeaways

This study investigates early signs of insulin resistance, a precursor to type 2 diabetes.
It examines a protein called Rab3 and its role in sugar processing.
A three-week diet and exercise plan is used to see if insulin sensitivity improves.
Researchers will also study the link between gut bacteria and insulin sensitivity.
The goal is to find better ways to understand and prevent type 2 diabetes.

Who may be eligible?

To join this study, you need to be a man or a woman between 40 and 65 years old. Your Body Mass Index (BMI) should be between 25 and 40, which generally means you are overweight or have obesity. You should also have a waist size greater than 80 cm for women or 94 cm for men. We're looking for people who don't do a lot of physical activity daily and whose weight has been stable for at least three months.

There are certain reasons why you wouldn't be able to join. For example, if you already have a diagnosis of diabetes or other metabolic disorders, or if you can't exercise for health reasons. We also can't include you if you've recently made big lifestyle changes, such as a major diet or exercise plan, or if your weight has changed dramatically recently. If you smoke, or have stopped smoking less than six months ago, you won't be able to participate. Similarly, if you have high blood pressure (higher than 160/100), heart problems, or a bleeding disorder, you won't be eligible.

Finally, if you've taken antibiotics in the last three months, or probiotics/prebiotics in the last month, or are currently taking certain anti-inflammatory medications (like NSAIDs) or blood thinners, you wouldn't be able to take part in this study.

Quick self-check

Are you between 40 and 65 years old?
Is your BMI (body weight in relation to height) between 25 and 40?
Do you generally have a less active lifestyle?
Have you had stable weight for the past three months?
Do you NOT have diagnosed diabetes or heart disease?
Have you NOT taken antibiotics in the last three months?

This is a guide only — the research team will confirm whether you can take part.

What does participation involve?

If you join this study, you will follow a specific controlled diet and exercise plan for three weeks. Before and after this period, you will have several assessments. These will include providing samples of fat and muscle tissue, which involves minor procedures, as well as providing stool samples. Your physical activity levels will be monitored. The total duration of your active participation in the study, including all assessments and the three-week intervention, will be clearly explained to you.

Potential risks and benefits

Participating in this study might offer you some benefits, such as gaining a better understanding of your own health and potentially improving your insulin sensitivity through the diet and exercise plan. However, there are also some risks, such as discomfort or minor complications from the procedures to collect fat and muscle samples. There might also be some inconvenience from following a controlled diet and exercise routine. We want to assure you that your participation is completely voluntary, and you have the right to withdraw from the study at any time, for any reason, without it affecting your medical care.

Locations (1)

Department for Health, University of Bath
Bath, United Kingdom

Common questions

What is insulin resistance?

Insulin resistance means your body's cells don't respond properly to insulin, making it harder for sugar to get out of your blood and into your cells. This can lead to higher blood sugar levels and may eventually cause type 2 diabetes.

What is Rab3?

Rab3 is a small protein that helps move sugar-transporting doorways (called GLUT4) to the surface of your muscle and fat cells. This helps get sugar out of your blood. We think low levels of Rab3 might be linked to insulin resistance.

What is the gut microbiome?

The gut microbiome is the community of bacteria and other tiny organisms living in your intestines. They play a role in digestion, and we're researching if they also affect how your body handles insulin.

Will I have to take any new medication?

No, this study does not involve taking new medications. The intervention focuses on a controlled diet and exercise plan.

How long will the study intervention last?

The main intervention, involving the controlled diet and exercise, will last for three weeks. You will also have assessments before and after this period.