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Clinical trial Recruiting at 1 site Interventional Ages 45 to 79

Pancreatic fat and diabetes remission after weight loss

Official title: Mechanisms Mediating Reversible Lipotoxicity of the Pancreas in Obesity-induced Type 2 Diabetes: Edinburgh Diabetes Remission Study (EDRS)

Run by University of Edinburgh · NCT07364045 · Data updated 2026-11-12

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.

More Type 2 Diabetes trials

Quick facts

Study typeInterventional
Ages45 Years to 79 Years
SexAll
Enrollment104 (estimated)
SponsorUniversity of Edinburgh
Academic / other
Locations1 site (Edinburgh)
StatusRecruiting
StartedJune 15, 2026
Main results expectedMarch 30, 2029
Study endsDecember 31, 2029
Registry record updatedJune 18, 2026
Trial IDNCT07364045 on ClinicalTrials.gov

Is this trial a fit for you?

Likely a 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.

Probably 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.

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

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.

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 gone: 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.

Who can join: the full rules

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 it's running

  • Clinical Research Facility, Royal Infirmary of Edinburgh
    Edinburgh, United Kingdom     Recruiting

Study contacts

Similar studies

Other studies for the same condition or treatment. Recruiting studies are listed first.

How to take part

  1. Review the eligibility criteria above with your treating physician.
  2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
  3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.
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Last reviewed 2026-11-14 by the Find a Trial editorial team. Information on this page is for educational purposes and is not medical advice. Always consult qualified healthcare professionals about clinical trial participation.