The eHealth Diabetes Remission Trial

NCT ID: NCT05491005

Last Updated: 2024-07-01

Basic Information

• Recruitment Status: RECRUITING
• Clinical Phase: NA
• Total Enrollment: 106 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2022-08-31
• Study Completion Date: 2026-12-31

Brief Summary

Overweight patients with type 2 diabetes are offered a total diet replacement with the goal of weight loss and diabetes remission. Study participants are randomised to eHealth follow-up or face-to-face follow-up, but the dietary advice is the same in both groups. A healthy control group with normal glucose tolerance is examined once but is not randomised and does not receive any intervention.

Detailed Description

One hundred and six overweight patients with type 2 diabetes replace usual foods with total diet replacement (850 kcal/day) for 3 months with the goal of 15 kg weight loss and diabetes remission (HbA1c < 48 mmol/mol without diabetes medication). After 3 months of total diet replacement, food is reintroduced stepwise, and an individually tailored energy prescription is used to prevent weight regain. If study participants do not reach the weight loss goal at 3 months, they are recommended two additional months of total diet replacement. If weight regain occurs during the weight maintenance phase, a rescue plan with total diet replacement will be recommended. To increase the chances to maintain their lower body weight, participants will use a program specifically design for that purpose based on cognitive behavioural therapy. Total study duration is two years.

The one hundred and six participants are randomised to either the eHealth follow-up or the face-to-face follow-up. The dietary advice to achieve and maintain weight loss is the same in both groups and delivered by the same dietician, physician, and nurse but the method of follow-up differs between groups (eHealth vs face-to-face).

eHealth group:

All study information and the cognitive behavioural therapy program is given by an eHealth application in Stöd och behandling which is part of 1177.se. Participants register body weight, fasting blood glucose, and blood pressure every morning at 1177.se. Regularly a measurement of HbA1c is taken at home. Participants will have scheduled video appointments with the study dietician, study nurse or study physician.

Face-to-face group:

Participants have appointments in the medical office with the study physician/nurse/dietician. At the appointments, body weight, blood pressure and capillary blood glucose is measured. HbA1c is measured during the appointments at 0, 6, 12 and 24 months. The cognitive behavioral therapy program for the control group is identical to the program of the intervention group, but the program is delivered during the face-to-face appointments.

Healthy control group:

Fifteen healthy participants with normal glucose tolerance, stable body weight for at least one year and matched to the study participants for sex, age, and weight after one year study duration, will be examined once. These participants are not randomised and do not receive any intervention.

Outcomes:

Primary and secondary outcome measures are compared between 1) the experimental eHealth group and 2) the experimental face-to-face group. For the other pre-specified outcome measures the experimental eHealth group and the experimental face-to-face group are taken together as one group, examined twice (baseline and 12 months) and compared to the healthy control group, that is examined only once.

Long-term follow-up:

Because long term data on diabetes remission by total diet replacement are lacking, study participants will be followed after they have finished the study. Data of the national diabetes registry from participants of this study will be compared to other patients in the national diabetes registry not participating in this study but matched for age, sex and diabetes duration to the study participants.

Conditions

Diabetes Mellitus, Type 2

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: SINGLE

Study Groups

eHealth

Group Type: EXPERIMENTAL

Total diet replacement

Intervention Type: BEHAVIORAL

Total diet replacement (850 kcal/day) for 3 months followed by weight maintenance for 21 months.

eHealth

Intervention Type: BEHAVIORAL

All follow-up through an eHealth application and video meetings.

Face-to-face

Group Type: EXPERIMENTAL

Total diet replacement

Intervention Type: BEHAVIORAL

Total diet replacement (850 kcal/day) for 3 months followed by weight maintenance for 21 months.

Face-to-face

Intervention Type: BEHAVIORAL

All follow-up through face-to-face meetings.

Healthy control group

Group Type: NO_INTERVENTION

No interventions assigned to this group

Interventions

Total diet replacement

Total diet replacement (850 kcal/day) for 3 months followed by weight maintenance for 21 months.

Intervention Type: BEHAVIORAL

eHealth

All follow-up through an eHealth application and video meetings.

Intervention Type: BEHAVIORAL

Face-to-face

All follow-up through face-to-face meetings.

Intervention Type: BEHAVIORAL

Eligibility 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

• Minimum Eligible Age: 20 Years
• Maximum Eligible Age: 70 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

Region Västerbotten

OTHER_GOV

Sponsor Role: collaborator

Edgar Sjölunds Diabetes Foundation

UNKNOWN

Sponsor Role: collaborator

Umeå University

OTHER

Sponsor Role: lead

Responsible Party

Julia Otten

Principal investigator

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Julia Otten, PhD

Role: PRINCIPAL_INVESTIGATOR

Umeå University

Locations

Bra Liv Råslätt vårdcentral

Jönköping, , Sweden

Site Status: RECRUITING

Örnsköldsvik hospital

Örnsköldsvik, , Sweden

Site Status: NOT_YET_RECRUITING

Department of Public Health and Clinical Medicine, Medicine

Umeå, , Sweden

Site Status: RECRUITING

Countries

Sweden

Central Contacts

Julia Otten, PhD

Role: CONTACT

julia.otten@umu.se

+46703341559

Facility Contacts

Andreas Stomby, PhD

Role: primary

Katarina Shahedi, MD

Role: primary

Julia Otten, MD, PhD

Role: primary

References

Tsapas A, Avgerinos I, Karagiannis T, Malandris K, Manolopoulos A, Andreadis P, Liakos A, Matthews DR, Bekiari E. Comparative Effectiveness of Glucose-Lowering Drugs for Type 2 Diabetes: A Systematic Review and Network Meta-analysis. Ann Intern Med. 2020 Aug 18;173(4):278-286. doi: 10.7326/M20-0864. Epub 2020 Jun 30.

Reference Type: BACKGROUND

PMID: 32598218 (View on PubMed)

Otten J, Tellstrom A, Schien C, Chninou Y, Lindholm L, Winkvist A, Liv P, Stomby A. eHealth versus face-to-face support for remission of type 2 diabetes by calorie restriction (eHealth DIabetes remission Trial): study protocol for a non-inferiority parallel group randomised controlled trial. BMJ Open. 2025 Jul 22;15(7):e095100. doi: 10.1136/bmjopen-2024-095100.

Reference Type: DERIVED

PMID: 40701606 (View on PubMed)

Other Identifiers

Dnr 2022-02242-01

Identifier Type: -

Identifier Source: org_study_id