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New treatment option for Type 2 Diabetes
Official title Pancreas Lipotoxicity in T2D: Edinburgh Diabetes Remission Study (EDRS)
ClinicalTrials.gov ID: NCT07364045
What this study is testing
- What it's testing
- 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.
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Ages 45 to 79. Healthy volunteers may be eligible.
You may be able to join if
- 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...
- 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).
You likely can't join if
- 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)
See the full eligibility 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.
- 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
The study team makes the final eligibility decision.
Where it's taking place
- Edinburgh, United Kingdom
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling all sexes, 45 years to 79 years. Healthy volunteers may be eligible. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include Edinburgh, United Kingdom. Enter your location above to see the nearest site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from ClinicalTrials.gov; the study team decides eligibility.