Clinical trial NCT05491005: The eHealth Diabetes Remission Trial
Official title: eHealth Diabetes Remission Trial (Swedish: Remission av Typ 2 Diabetes Med hjälp av eHälsa
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Diabetes Mellitus, Type 2
Keywords: Diabetes Remission
Nutrition Therapy
Obesity
eHealth
Weight Loss
Lead sponsor: Umeå University
Sponsor class: OTHER
Collaborators: name: Region Västerbotten
name: Edgar Sjölunds Diabetes Foundation
First posted: 2022-08-08
Enrollment: 106
Sex: ALL
Minimum age (years): 20
Maximum age (years): 70
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.

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

Primary outcomes:
measure: HbA1c
timeFrame: 12 months
Secondary outcomes:
measure: HbA1c
timeFrame: 6 and 24 months
measure: Diabetes remission
timeFrame: 6, 12 and 24 months
measure: Body weight
timeFrame: 6, 12 and 24 months
measure: Achieved weight loss of at least 15 kg
timeFrame: 6, 12 and 24 months
measure: Incremental costs per diabetes remission
timeFrame: 24 months
measure: Estimated lifetime costs
timeFrame: 24 months
measure: Estimated lifetime costs per quality-adjusted life-year (QALY)
timeFrame: 24 months
measure: Fasting blood glucose
timeFrame: 6, 12, 24 months
measure: P-glucose 120 minutes after the oral glucose tolerance test
timeFrame: 6, 12, 24 months
measure: Number of prescribed oral anti diabetic medications
timeFrame: 6, 12, 24 months
measure: Number of prescribed antihypertensive medications
timeFrame: 6, 12, 24 months
measure: Blood pressure (systolic/diastolic)
timeFrame: 6, 12, 24 months
measure: Blood pressure
timeFrame: 6, 12, 24 months
measure: Plasma lipid profile
timeFrame: 6, 12, 24 months
measure: Liver enzymes
timeFrame: 6, 12, 24 months
measure: Number of participants that discontinue the intervention
timeFrame: 6, 12, 24 months
measure: Waist circumference
timeFrame: 6, 12, 24 months
measure: Relation to food
timeFrame: 6, 12, 24 months
measure: Estimation of exhaustion
timeFrame: 6, 12, 24 months
measure: Quality of life accoring to Brunnsviken Brief Quality of Life Scale
timeFrame: 6, 12, 24 months
measure: Quality of life according to EQ-5D-5L
timeFrame: 6, 12, 24 months
measure: Eating habits
timeFrame: 6, 12, 24 months
measure: Estimation of health
timeFrame: 6, 12, 24 months
measure: Daily steps
timeFrame: 6, 12, 24 months
measure: Study experience
timeFrame: 24 months
measure: HbA1c follow-up
timeFrame: Yearly up to 20 years
measure: Body weight follow-up
timeFrame: Yearly up to 20 years
measure: Blood pressure follow-up
timeFrame: Yearly up to 20 years
measure: Usage of diabetes medication follow-up
timeFrame: Yearly up to 20 years
measure: Usage of hypertension medication follow-up
timeFrame: Yearly up to 20 years
measure: Diabetes complications follow-up
timeFrame: Yearly up to 20 years
Other outcomes:
measure: Insulin sensitivity
timeFrame: 12 months
measure: Insulin secretion
timeFrame: 12 months
measure: Metabolic flexibility
timeFrame: 12 months
measure: Resting metabolic rate
timeFrame: 12 months
measure: Body composition
timeFrame: 12 months
measure: Glucagon sensitivity
timeFrame: 12 months
measure: Amino acid tolerance
timeFrame: 12 months
measure: Glucagon secretion capacity
timeFrame: 12 months
measure: Gut hormones after carbohydrate intake
timeFrame: 6, 12, 24 months
measure: P-metabolites and P-lipids after carbohydrate intake
timeFrame: 6, 12, 24 months
measure: Liver fat
timeFrame: 12 months
measure: Pancreas fat
timeFrame: 12 months
measure: Fat cell size in subcutaneous fat
timeFrame: 12 months
measure: RNA levels in subcutaneous fat
timeFrame: 12 months
measure: Secretion of adipokines, metabolites and lipids in subcutaneous fat cells ex vivo
timeFrame: 12 months
measure: Plasma testosterone levels
timeFrame: 6, 12 and 24 months
measure: Erectile function
timeFrame: 6, 12, 24 months
measure: Prostate symptoms
timeFrame: 6, 12, 24 months
measure: Urine albumin to creatinine ratio
timeFrame: 6, 12, 24 months
measure: Slow vital capacity (SVC)
timeFrame: 12 months
measure: Forced vital capacity (FVC)
timeFrame: 12 months
measure: Forced expiratory volume in 1 s (FEV1)
timeFrame: 12 months
measure: Diffusion capacity of the the (DCLO)
timeFrame: 12 months
measure: Experiences of the study participants
timeFrame: Once between 12 and 24 months
Locations:
city: Jönköping
country: Sweden
facility: Bra Liv Råslätt vårdcentral
city: Umeå
country: Sweden
facility: Department of Public Health and Clinical Medicine, Medicine
city: Örnsköldsvik
country: Sweden
facility: Örnsköldsvik hospital
Study officials:
affiliation: Umeå University
name: Julia Otten, PhD
role: PRINCIPAL_INVESTIGATOR
References:
citation: 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.