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Pancreas Lipotoxicity in T2D: Edinburgh Diabetes Remission Study (EDRS)

RecruitingNAAges 45 Years - 79 YearsAllUniversity of Edinburgh
NCT07364045 on ClinicalTrials.gov ↗
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In plain words

What the trial is, and whether it could suit you

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 progr

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📋 Eligibility rules (as published)
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
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What it tests

  • Total Diet Replacement (TDR) Program
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Where

1 site
Clinical Research Facility, Royal Infirmary of Edinburgh
Edinburgh, United Kingdom
🤝 Taking part is your choice, and you can leave at any time. Only the trial team can confirm you are eligible — always decide together with your own doctor.
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