Department of Public Health and Clinical Medicine, Medicine
Umeå, 90187, Sweden
NCT Number: NCT04805996
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.
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Notify Me20 year–65 year
All sexes
Interventional
Not applicable
Umeå, 90187, Sweden
Healthy volunteers accepted: No
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
Exclusion criteria
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.
Time frame: 6 months
Weight loss goal of 15 kg, measured at the research facilities
Time frame: 6 months
The goal is diabetes remission with HbA1c < 48 mmol/mol without any diabetes medication. (Secondary goal < 42 mmol/mol.)
Time frame: 6 months
Time frame: Daily measurements up to 6 months
Partial diabetes remission (< 7.0 mol/l), complete diabetes remission (<6.1 mol/l)
Time frame: 6 months
Partial diabetes remission (<7.0 mol/l), complete diabetes remission (<6.1 mol/l) without diabetes medication.
Time frame: 6 months
Measured at the research facilities
Time frame: At baseline, 3 months and 6 months
Measured with oral glucose tolerance test
Time frame: At baseline, 3 months and 6 months
Measured with oral glucose tolerance test
Time frame: At baseline, 3 months and 6 months
Measured with indirect calorimetry during oral glucose tolerance test
Time frame: At baseline, 3 months and 6 months
Measured at the research facilities
Time frame: Daily measurements up to 6 months
Measured at home
Time frame: 6 months
Change of blood pressure medication during the study
Time frame: Daily measurements up to 6 months
Measured at home
Time frame: Monthly measurement up to 6 months
Measured at home
Time frame: 6 months
Change of diabetes medication during study duration
Time frame: At baseline, 3 months and 6 months
Measured at the research facilities
Time frame: Baseline, 3 months and 6 months
Measured in cm at the research facilities
Time frame: At baseline, 3 months and 6 months
Questionnaire
Time frame: At baseline and 6 months
Questionnaire
Time frame: During the second three months of the study
Measured with activity tracker
Time frame: Yearly up to 20 years
Collected from patient journals after study completion
Time frame: Yearly up to 20 years
Collected from patient journals after study completion
Time frame: Yearly up to 20 years
Collected from patient journals after study completion
Time frame: Yearly up to 20 years
Collected from patient journals after study completion
Time frame: Yearly up to 20 years
Collected from patient journals after study completion
Time frame: Yearly up to 20 years
Collected from patient journals and registries after study completion
Julia Otten
Other
Acronym: eDIT-pilot
OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.
View the official ClinicalTrials.gov record (opens in a new tab)This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.
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