At a glance
- What the study gets you
- Access to the study treatment being tested
- Type of study
- Interventional (receives a drug or procedure)
- Time in hospital
- In-person visits at study sites — visit count not specified by the sponsor
- Drug or intervention
- Total Diet Replacement (TDR) Program (behavioural)
- How long the study runs
- Study runs about 42 months (dates as stated)
- About the drug or intervention
- Total Diet Replacement (TDR) Program — behavioural: Participants will follow a structured Total Diet Replacement (TDR) program consisting of approximately 800 kcal/day using commercially available soups and shakes for 8-12 weeks.
- Patient visit burden
- Not specified by the sponsor
- Type of study
- Testing a treatment
- Ages
- 45 Years to 79 Years
- Who
- All
- Number of participants
- 104
- Started
- 2026-06-15
- Last checked
- 2026-06
Plain English Summary
What is this study?
- • Testing a new treatment for type 2 diabetes
- • NA - 104 participants
- • 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
Who can take part?
- • Ages 45 Years to 79 Years
- • Diagnosed with type 2 diabetes
Where?
- • Edinburgh - Clinical Research Facility, Royal Infirmary of Edinburgh
This is a simplified summary. Always discuss with your doctor before making any decisions.
About This Trial
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.
How this trial compares with your answers
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What we know so far
Still need:
- • Tell us your age for better matching
- • Tell us your sex for better matching
Preliminary match based on your answers. Full eligibility requires on-site assessment including medical history, physical exam, and lab tests. This does not guarantee enrolment.
Eligibility at a Glance
Key info
- Age: 45 Years - 79 Years
- Who can join: All genders
What the study is looking for
- ✓Overweight/obese (BMI: 30-45 kg/m²) who have had T2D for less than 6 years or longer than 10 years, and are on...
- ✓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).
Who cannot take part
- ✗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
See the full criteria
Where Is This Study? (1 UK site)
Clinical Research Facility, Royal Infirmary of Edinburgh
Edinburgh EH16 4SA, United Kingdom
How to Get in Touch
Study Team
Sponsor contactCONTACT