Weight loss program for overweight patients with type 2 diabetes
eHealth Diabetes Remission Trial (Swedish: Remission av Typ 2 Diabetes Med hjälp av eHälsa
This study is testing a weight loss program for overweight people with type 2 diabetes to see if a strict diet and different types of support can help them lose weight and possibly improve their diabetes over two years.
Quick facts
| Phase | Not applicable |
|---|---|
| Study type | Interventional |
| Enrollment | 106 (estimated) |
| Ages | 20 Years to 70 Years |
| Sex | All |
| Sponsor | Umeå University Academic / other |
| Locations | 3 sites (Jönköping and 2 other locations) |
| Trial ID | NCT05491005 on ClinicalTrials.gov |
What this trial studies
This trial involves overweight patients with type 2 diabetes who undergo a total diet replacement of 850 kcal/day for three months, aiming for a weight loss of 15 kg and potential diabetes remission. Participants are randomized into two groups: one receiving eHealth follow-up and the other receiving face-to-face follow-up, although both groups receive the same dietary advice. After the initial three months, food is gradually reintroduced, and a tailored energy prescription is provided to prevent weight regain. The total duration of the study is two years, with ongoing support through cognitive behavioral therapy to help maintain weight loss.
Who should consider this trial
Good fit: Ideal candidates are overweight individuals with type 2 diabetes diagnosed within the last six years and a BMI of 27 kg/m2 or higher.
Not a fit: Patients currently on insulin treatment or with severe health conditions such as recent myocardial infarction or severe heart failure may not benefit from this study.
Why it matters
Potential benefit: If successful, this program could lead to significant weight loss and remission of type 2 diabetes for participants.
How similar studies have performed: Other studies have shown promising results with similar dietary interventions for diabetes remission, indicating potential for success in this approach.
Eligibility criteria
Show full inclusion / exclusion criteria
Inclusion Criteria: * Type 2 diabetes with duration 0-6 years * BMI 27 kg/m2 and higher * HbA1c 43 mmol/mol or higher (48 or higher if without diabetes medication) Exclusion Criteria: * Insulin treatment * Weight loss more than 5 kg during the past 6 months * Diagnosed eating disorder * eGFR \< 30 ml/min/1,73m2 * Myocardial infarction last six months * Severe heart failure (NYHA class III) * Ongoing cancer * Pregnancy * Treatment with antipsychotic drugs
Where this trial is running
Jönköping and 2 other locations
- Bra Liv Råslätt vårdcentral — Jönköping, Sweden (Recruiting)
- Örnsköldsvik hospital — Örnsköldsvik, Sweden (Not_yet_recruiting)
- Department of Public Health and Clinical Medicine, Medicine — Umeå, Sweden (Recruiting)
Study contacts
- Principal investigator: Julia Otten, PhD — Umeå University
- Study coordinator: Julia Otten, PhD
- Email: julia.otten@umu.se
- Phone: +46703341559
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.