NCT07364045 Pancreas Lipotoxicity in T2D: Edinburgh Diabetes Remission Study (EDRS)
| NCT ID | NCT07364045 |
| Status | Recruiting |
| Phase | — |
| Sponsor | University of Edinburgh |
| Condition | Type 2 Diabetes |
| Study Type | INTERVENTIONAL |
| Enrollment | 104 participants |
| Start Date | 2026-06-15 |
| Primary Completion | 2029-03-30 |
Eligibility & Interventions
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What to Expect as a Participant
You will actively receive the study intervention — which may be a drug, biologic, device, or procedure.
This trial targets 104 participants in total. It began in 2026-06-15 with a primary completion date of 2029-03-30.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
Brief Summary
This study aims to investigate how fat accumulation in the pancreas contributes to the development of type 2 diabetes (T2D), and how weight loss may reverse this process. Previous research has shown that reducing body weight can lead to diabetes remission, and this was accompanied by lowering intrapancreatic fat and restoration of insulin secretion, but the mechanisms behind this are not fully understood. In particular, the study aims to unravel the role of hepatic de novo lipogenesis (DNL) and lipoprotein metabolism on pancreas lipotoxicity and beta cell recovery after weight loss. Four groups of participants will be recruited (n=26 per group): non-diabetic, pre-diabetic, short-duration T2D (\<6 years), and long-duration T2D (\>10 years). Participants will be aged between 45 and 79 years and have a BMI between 30 and 45 kg/m². All participants will follow a structured weight loss programme using an 800 kcal/day Total Diet Replacement (TDR) for 8-12 weeks, followed by dietary support to maintain weight loss. The study is sponsored by NHS-Lothian and the University of Edinburgh and will be carried out at the Clinical Research Facility, Royal infirmary of Edinburgh by a specialist team (Senior Diabetes Research Nurse, Clinical Fellow, and Research Dietitian). The primary endpoint of this study is to achieve a 10-15% reduction in body weight (\~10 kg) through a low-calorie diet (800 kcal/day) to induce T2D remission and maintain this weight loss with structured dietary support for up to 6-12 months. The primary aim is to compare hepatic de novo lipogenesis-the conversion of sugar into fat by the liver-and lipoprotein export among the groups, and to examine how these parameters change in response to weight loss, improvement in metabolic status, and restoration of normal pancreatic function. Secondary endpoints include changes in weight, HbA1c, intraorgan fat (liver/pancreas), pancreas volume and tissue characteristics, beta cell mass and function (MRI/mixed meal test), circulating blood markers (i.e. lipids, exosomes, adipokines, and inflammatory markers), and the change in adipose tissue biology (fat biopsies). Ultimately, this study aims to understand the mechanisms of T2D remission. It will help clarify the sequence of metabolic events leading to reversible pancreatic lipotoxicity and may inform the development of new, targeted therapies for T2D.
Eligibility Criteria
Inclusion Criteria: * Overweight/obese (BMI: 30-45 kg/m²) who have had T2D for less than 6 years or longer than 10 years, and are on treatment with diet alone or diet plus oral medication. * Overweight/obese (BMI: 30-45 kg/m²) who are at pre-diabetes stage, defined as fasting blood glucose 5.6-6.9 mmol/L. * Overweight/obese (BMI: 30-45 kg/m²) who are non-diabetic (control group). * Age between 45 and 79 years inclusive. * Post-menopausal women only (to exclude sex hormone effects on lipid metabolism). * Good communication in English (able to give informed consent and follow dietary advice). * Willing and able to adhere to the study protocol, including dietary intervention and scheduled follow-up visits. Exclusion Criteria: * Insulin therapy * HbA1c \>12% (108 mmol/mol) * Weight loss \>5 kg in last 6 months * Recent MI (within 6 months) * Known cancer in last 5 years * First-degree relatives of people with T2D (control group) * History of gestational diabetes * MRI contraindications (metal implants, claustrophobia) * Alcohol \>14 units/week * Advanced kidney or liver disease * Use of steroids or antipsychotics * Participation in another clinical trial * Life expectancy \<1 year * Allergy to local anaesthetic (for biopsy subgroup) * Any disorder that may jeopardise safety or compliance
Contact & Investigator
Ahmad Al-Mrabeh, PhD
PRINCIPAL INVESTIGATOR
University of Edinburgh
Frequently Asked Questions
Who can join the NCT07364045 clinical trial?
This trial is open to participants of all sexes, aged 45 Years or older, up to 79 Years, studying Type 2 Diabetes. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
Is NCT07364045 currently recruiting?
Yes, NCT07364045 is actively recruiting participants. Contact the research team at edrs@ed.ac.uk for enrollment information.
Where is the NCT07364045 trial being conducted?
This trial is being conducted at Edinburgh, United Kingdom.
Who is sponsoring the NCT07364045 clinical trial?
NCT07364045 is sponsored by University of Edinburgh. The principal investigator is Ahmad Al-Mrabeh, PhD at University of Edinburgh. The trial plans to enroll 104 participants.
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