Type 2 Diabetes
Conditions
Keywords
diabetes remission, weight loss, low-calorie diet, eHealth
Brief summary
Ten study participants will consume a low-calorie total diet replacement for 12 weeks, have a 6-week food reintroduction phase (week 13-18) and continue with the weight loss maintenance phase until the end of the study (week 19-26). The weight loss goal is 15 kg (or 15% if body weight is bellow 80 kg). The primary study outcome iw weight loss after 6 months and the co-primary outcome is diabetes remission after 6 months (HbA1c \< 48 mmol/mol). During the weight maintenance phase, if weight regain occurs or if HbA1c increases a rescue plan of total diet replacement will be recommended. The participants will be supplied with the total diet replacement Modifast free of charge. Participants will be supplied with a scale, a finger-stick blood glucose meter and a blood pressure monitor. Participants will be advised to measure body weight, blood glucose and blood pressure every morning. The results are registered in the mobile phone application Telia Health Monitoring and are wirelessly transmitted to the project's physician, nurse and dietician. At the beginning of the food reintroduction phase the participants will receive an activity tracer and will be advised to increase their physical activity. Primary and secondary outcome measures will be estimated at the beginning and after 3 and 6 months. At the end of the study, all participants will take part in an individual semi-structured interview to investigate the participants' experience of diabetes remission and of the eHealth contact with the healthcare provider. After participants have completed the study, they will be followed at least once per year by obtaining data on blood sugar, HbA1c, body weight, blood pressure, medication usage and diabetes complications from the healthcare computer system.
Interventions
BEHAVIORALDiabetes remission using total diet replacement and eHealth contact with the healthcare provider
Participants will replace usual foods with the commercially available total diet replacement Modifast (Impolin AB), which is delivered to them during the study period without any cost. Participants will be supplied with a scale, a finger-stick blood glucose meter and a blood pressure monitor and will be advised to measure body weight, fasting blood glucose and blood pressure every morning. The results are registered in the mobile phone application Telia Health Monitoring (Telia Sweden AB) and are wirelessly transmitted to the study team.
Sponsors
Region Västerbotten
Julia Otten
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
20 Years to 65 Years
Healthy volunteers
No
Inclusion criteria
* Type 2 diabetes with diabetes duration 0 to 6 years * BMI 27-45 kg/m2 * Owning a smartphone * HbA1c 43-107 mmol/mol during the past 12 months (48-107 mmol/mol without blood sugar lowering medication)
Exclusion criteria
* Insulin treatment * Weight loss 5 kg or more during the past 6 months * Treatment with weight loss medication * Diagnosed eating disorder * eGFR \< 30 ml/min/1.73m2 * Substance abuse * Cancer * Myocardial infarction during the past 6 months * Severe heart failure * Pregnancy
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Weight loss | 6 months | Weight loss goal of 15 kg, measured at the research facilities |
| HbA1c | 6 months | The goal is diabetes remission with HbA1c \< 48 mmol/mol without any diabetes medication. (Secondary goal \< 42 mmol/mol.) |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Blood pressure follow up (systolic/diastolic) | Yearly up to 20 years | Collected from patient journals after study completion |
| Antidiabetic medication usage follow up | Yearly up to 20 years | Collected from patient journals after study completion |
| Semi-structured interviews | 6 months | — |
| Fasting blood glucose | Daily measurements up to 6 months | Partial diabetes remission (\< 7.0 mol/l), complete diabetes remission (\<6.1 mol/l) |
| P-glucose 120 minutes after the oral glucose tolerance test | 6 months | Measured at the research facilities |
| Insulin secretion | At baseline, 3 months and 6 months | Measured with oral glucose tolerance test |
| Insulin sensitivity | At baseline, 3 months and 6 months | Measured with oral glucose tolerance test |
| Metabolic flexibility | At baseline, 3 months and 6 months | Measured with indirect calorimetry during oral glucose tolerance test |
| Blood pressure (systolic/diastolic) | At baseline, 3 months and 6 months | Measured at the research facilities |
| Blood pressure medication | 6 months | Change of blood pressure medication during the study |
| Blood pressure medication usage follow up | Yearly up to 20 years | Collected from patient journals after study completion |
| HbA1c | Monthly measurement up to 6 months | Measured at home |
| Diabetes medication | 6 months | Change of diabetes medication during study duration |
| Plasma lipid profile | At baseline, 3 months and 6 months | Measured at the research facilities |
| Waist circumference | Baseline, 3 months and 6 months | Measured in cm at the research facilities |
| EQ-5D-5L | At baseline, 3 months and 6 months | Questionnaire |
| Food frequency form | At baseline and 6 months | Questionnaire |
| Daily steps | During the second three months of the study | Measured with activity tracker |
| HbA1c follow up | Yearly up to 20 years | Collected from patient journals after study completion |
| Body weight follow up | Yearly up to 20 years | Collected from patient journals after study completion |
| Body weight | Daily measurements up to 6 months | Measured at home |
| Diabetes complications follow up | Yearly up to 20 years | Collected from patient journals and registries after study completion |
Countries
Sweden
Outcome results
None listed