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RecruitingNAINTERVENTIONAL

Low Energy Diet and Familial Partial Lipodystrophy

Researchers are conducting a study to see how a special low-calorie diet can help people who have both familial partial lipodystrophy (a rare genetic condition affecting how the body stores fat) and type 2 diabetes. The aim is to understand if this diet can improve their health and manage their diabetes better. Participants will be given a complete diet replacement for 12 weeks, followed by a gradual return to regular food. We will then continue to see how they are doing for a whole year. For some participants, we will also take small samples of fat and muscle to get a better understanding of how the diet changes the body inside. This research could help find better ways to treat these conditions in the future.

At a glance

Status
Recruiting
Phase
NA
Sponsor
Cambridge University Hospitals NHS Foundation Trust
Enrolment target
20
Start
16 Jan 2020
Estimated completion
01 May 2025

What is this study about?

This study is investigating a new way to help people who have a rare genetic condition called familial partial lipodystrophy, which affects how fat is stored in the body, and also type 2 diabetes. The main goal is to find out if a very low-calorie diet can make a real difference to their health and help manage their diabetes more effectively.

For 12 weeks, participants will follow a special diet that completely replaces their usual meals with carefully planned low-calorie options. After this initial period, they will gradually reintroduce regular foods into their diet. The researchers will then continue to monitor their health for a full year to see the long-term effects of the diet.

To understand exactly how and why this diet helps, some participants will also be asked if they would like to provide small samples of their fat and muscle tissue at the beginning and after 12 weeks. These samples will be carefully studied to see changes at a tiny level, which can help explain how the diet improves the body's use of sugar and its overall health. This information is really important for developing better treatments in the future.

Key takeaways

  • Tests a strict low-calorie diet for 12 weeks.
  • Aims to improve health for people with familial partial lipodystrophy and type 2 diabetes.
  • Involves a year of monitoring your health.
  • Optional tissue samples to understand how the diet works.
  • Could help find better treatments in the future.

Who may be eligible?

To be considered for this study, you must have familial partial lipodystrophy and type 2 diabetes. You also need to be 18 years old or older and willing to check your blood sugar levels every day. Your diabetes should be reasonably controlled, with a specific range for your HbA1c (a measure of average blood sugar over a few months), and your weight should have been stable for the three months before joining. It's also important that you're able to understand the study details and give your permission to take part.

There are certain reasons why you might not be able to join. For example, if you are pregnant, have untreated problems with your thyroid gland, or are taking certain medications that can affect your diabetes control (such as steroids or some drugs for mental health). You also can't take part if you have a history of eating disorders, have had certain stomach operations like gastric bypass, or are currently receiving a treatment called Leptin therapy. Untreated eye problems related to diabetes would also prevent you from joining.

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.

  1. Do I have familial partial lipodystrophy and type 2 diabetes?
  2. Am I 18 years old or older?
  3. Can I check my blood sugar every day?
  4. Has my weight been stable for the last 3 months?
  5. Am I not pregnant and don't have untreated thyroid problems or eating disorders?
Answer every question to see your result.

What does participation involve?

If you decide to take part, the study will last for a total of one year. For the first 12 weeks, you will be on a special low-calorie diet where you will get all your food from the study team. After these 12 weeks, you will slowly go back to eating regular food with guidance from the study team. Throughout the year, you will have regular check-ups and assessments to monitor your health and how the diet is affecting you. For some participants, with their agreement, there will also be two extra procedures: one at the start of the study and one after 12 weeks, where a tiny sample of fat and muscle tissue will be taken. You will need to take daily blood sugar readings at home.

Potential risks and benefits

Taking part in this study could potentially help improve your diabetes control and overall health linked to your familial partial lipodystrophy. However, following a very low-calorie diet can be challenging and might lead to side effects like tiredness or headaches, especially at the beginning. The tissue sampling procedures, if you choose to have them, involve minor risks such as bruising or discomfort. You are in control and can decide to leave the study at any time, for any reason, without it affecting your medical care.

Locations (1)

Some site locations are approximate. We're improving this — please verify with the trial team before travelling.
  • Cambridge University Hospital NHS Foundation Trust
    Verified postcode
    Cambridge, United Kingdom· Recruiting

Common questions

What is familial partial lipodystrophy?

It's a rare genetic condition where your body doesn't store fat normally, which can lead to various health problems, including diabetes.

Will I get all my food from the study?

Yes, for the first 12 weeks, the study will provide all your meals as part of the total diet replacement plan.

What is an HbA1c test?

It's a blood test that shows your average blood sugar levels over the past 2-3 months, giving an idea of your diabetes control.

Do I have to give tissue samples?

No, it's completely your choice. It's an optional part of the study to help researchers understand more, but you can still participate without having it done.

How long will the study last?

The study will last for a total of one year, with the special diet phase lasting 12 weeks at the start.

How to find out more

Mandour O Mandour

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

Interested in taking part?

Register your interest

Share your details and the research team for "Low Energy Diet and Familial Partial Lipodystrophy…" will contact you if you may be eligible. Always speak to your GP before agreeing to take part.

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