Pancreatic fat and diabetes remission after weight loss
Mechanisms Mediating Reversible Lipotoxicity of the Pancreas in Obesity-induced Type 2 Diabetes: Edinburgh Diabetes Remission Study (EDRS)
NA · University of Edinburgh · NCT07364045
This project will try to see if an 8–12 week very low‑calorie diet reduces pancreatic fat and helps restore insulin secretion in obese adults aged 45–79 with non‑diabetes, prediabetes, or type 2 diabetes.
Quick facts
| Phase | NA |
|---|---|
| Study type | Interventional |
| Enrollment | 104 (estimated) |
| Ages | 45 Years to 79 Years |
| Sex | All |
| Sponsor | University of Edinburgh (other) |
| Locations | 1 site (Edinburgh) |
| Trial ID | NCT07364045 on ClinicalTrials.gov |
What this trial studies
The study will recruit four groups (non‑diabetic, prediabetic, short‑duration T2D <6 years, and long‑duration T2D >10 years), with about 26 people per group, all aged 45–79 and with BMI 30–45 kg/m². All participants will follow an 800 kcal/day Total Diet Replacement (TDR) for 8–12 weeks followed by structured dietary support, with repeated metabolic and imaging measurements. Investigators will measure intrapancreatic fat, hepatic de novo lipogenesis, lipoprotein metabolism, and beta cell function to link changes in liver and lipid metabolism with pancreas lipotoxicity and insulin recovery. The goal is to clarify mechanisms behind diabetes remission after weight loss and why some people regain insulin secretion while others do not.
Who should consider this trial
Good fit: Adults aged 45–79 with BMI 30–45 kg/m², including men and post‑menopausal women, who are non‑diabetic, prediabetic, or have short (<6 years) or long (>10 years) duration type 2 diabetes and are willing to follow a strict low‑calorie diet are ideal candidates.
Not a fit: People on insulin, with very high HbA1c (>12%), recent significant weight loss, recent heart attack, recent cancer, MRI contraindications, or who cannot follow the diet or attend visits are unlikely to benefit from this protocol.
Why it matters
Potential benefit: If successful, this approach could help more people with type 2 diabetes achieve remission by targeting pancreatic fat and the metabolic pathways that damage insulin‑producing cells.
How similar studies have performed: Previous weight‑loss studies, including intensive low‑calorie programmes, have shown diabetes remission and reduced pancreatic fat, so this trial builds on demonstrated effects while probing underlying mechanisms.
Eligibility criteria
Show full inclusion / exclusion 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
Where this trial is running
Edinburgh
- Clinical Research Facility, Royal Infirmary of Edinburgh — Edinburgh, United Kingdom (RECRUITING)
Study contacts
- Principal investigator: Ahmad Al-Mrabeh, PhD — University of Edinburgh
- Study coordinator: Study Team
- Email: edrs@ed.ac.uk
- Phone: +44(0)131 242 6717
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.
Conditions: Type 2 Diabetes, Obesity, Remission, Weight loss