Ignite Creation Date:
2025-12-25 @ 3:27 AM
Ignite Modification Date:
2025-12-26 @ 2:07 AM
Study NCT ID:
NCT05491005
Status:
RECRUITING
Last Update Posted:
2024-07-01
First Post:
2022-08-03
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
The eHealth Diabetes Remission Trial
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D003924', 'term': 'Diabetes Mellitus, Type 2'}, {'id': 'D009765', 'term': 'Obesity'}, {'id': 'D015431', 'term': 'Weight Loss'}], 'ancestors': [{'id': 'D003920', 'term': 'Diabetes Mellitus'}, {'id': 'D044882', 'term': 'Glucose Metabolism Disorders'}, {'id': 'D008659', 'term': 'Metabolic Diseases'}, {'id': 'D009750', 'term': 'Nutritional and Metabolic Diseases'}, {'id': 'D004700', 'term': 'Endocrine System Diseases'}, {'id': 'D050177', 'term': 'Overweight'}, {'id': 'D044343', 'term': 'Overnutrition'}, {'id': 'D009748', 'term': 'Nutrition Disorders'}, {'id': 'D001835', 'term': 'Body Weight'}, {'id': 'D012816', 'term': 'Signs and Symptoms'}, {'id': 'D013568', 'term': 'Pathological Conditions, Signs and Symptoms'}, {'id': 'D001836', 'term': 'Body Weight Changes'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'D017216', 'term': 'Telemedicine'}], 'ancestors': [{'id': 'D003695', 'term': 'Delivery of Health Care'}, {'id': 'D010346', 'term': 'Patient Care Management'}, {'id': 'D006298', 'term': 'Health Services Administration'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'SINGLE', 'whoMasked': ['OUTCOMES_ASSESSOR']}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 106}}, 'statusModule': {'overallStatus': 'RECRUITING', 'startDateStruct': {'date': '2022-08-31', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2024-06', 'completionDateStruct': {'date': '2026-12-31', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2024-06-28', 'studyFirstSubmitDate': '2022-08-03', 'studyFirstSubmitQcDate': '2022-08-05', 'lastUpdatePostDateStruct': {'date': '2024-07-01', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2022-08-08', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2026-12-31', 'type': 'ESTIMATED'}}, 'outcomesModule': {'otherOutcomes': [{'measure': 'Insulin sensitivity', 'timeFrame': '12 months', 'description': 'Hyperinsulinemic euglycemic clamp'}, {'measure': 'Insulin secretion', 'timeFrame': '12 months', 'description': 'Stepped insulin secretion test with arginine'}, {'measure': 'Metabolic flexibility', 'timeFrame': '12 months', 'description': 'Hyperinsulinemic euglycemic clamp'}, {'measure': 'Resting metabolic rate', 'timeFrame': '12 months', 'description': 'Indirect calorimetry'}, {'measure': 'Body composition', 'timeFrame': '12 months', 'description': 'Dual-energy X-ray absorptiometry (DXA).'}, {'measure': 'Glucagon sensitivity', 'timeFrame': '12 months', 'description': 'Plasma amino acids are measured during 120 minutes after a intravenous glucagon bolus'}, {'measure': 'Amino acid tolerance', 'timeFrame': '12 months', 'description': 'Plasma amino acids are measured during intravenous amino acid infusion'}, {'measure': 'Glucagon secretion capacity', 'timeFrame': '12 months', 'description': 'Plasma glucagon is measured during intravenous amino acid infusion'}, {'measure': 'Gut hormones after carbohydrate intake', 'timeFrame': '6, 12, 24 months', 'description': 'GLP-1, GIP and gherkin during the oral glucose tolerance test'}, {'measure': 'P-metabolites and P-lipids after carbohydrate intake', 'timeFrame': '6, 12, 24 months', 'description': 'Metabolomics and lipidomics analyses during the oral glucose tolerance test'}, {'measure': 'Liver fat', 'timeFrame': '12 months', 'description': 'Measured with MRI'}, {'measure': 'Pancreas fat', 'timeFrame': '12 months', 'description': 'Measured with MRI'}, {'measure': 'Fat cell size in subcutaneous fat', 'timeFrame': '12 months'}, {'measure': 'RNA levels in subcutaneous fat', 'timeFrame': '12 months', 'description': 'RNA sequencing'}, {'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', 'description': 'Only men'}, {'measure': 'Erectile function', 'timeFrame': '6, 12, 24 months', 'description': 'Only men, Erectile function subscale'}, {'measure': 'Prostate symptoms', 'timeFrame': '6, 12, 24 months', 'description': 'Only men, International prostate symptom score'}, {'measure': 'Urine albumin to creatinine ratio', 'timeFrame': '6, 12, 24 months'}, {'measure': 'Slow vital capacity (SVC)', 'timeFrame': '12 months', 'description': 'Spirometry'}, {'measure': 'Forced vital capacity (FVC)', 'timeFrame': '12 months', 'description': 'Spirometry'}, {'measure': 'Forced expiratory volume in 1 s (FEV1)', 'timeFrame': '12 months', 'description': 'Spirometry'}, {'measure': 'Diffusion capacity of the the (DCLO)', 'timeFrame': '12 months', 'description': 'Spirometry'}, {'measure': 'Experiences of the study participants', 'timeFrame': 'Once between 12 and 24 months', 'description': 'Individual semi-structured interviews'}], 'primaryOutcomes': [{'measure': 'HbA1c', 'timeFrame': '12 months', 'description': 'HbA1c without diabetes medication as a continuous outcome (HbA1c correction according to Tsapas et al 2020 if on diabetes medication). The outcome will be tested for non-inferiority first, with a non-inferiority margin of 8 mmol/mol; followed by a test for superiority.'}], 'secondaryOutcomes': [{'measure': 'HbA1c', 'timeFrame': '6 and 24 months', 'description': 'HbA1c without diabetes medication as a continuous outcome (HbA1c correction according to Tsapas et al 2020 if on diabetes medication). The outcome will be tested for non-inferiority first, with a non-inferiority margin of 8 mmol/mol; followed by a test for superiority.'}, {'measure': 'Diabetes remission', 'timeFrame': '6, 12 and 24 months', 'description': 'Number of participants with HbA1c \\< 48 mmol/mol without diabetes medication. The outcome will be tested for non-inferiority first with a non-inferiority margin of 10 percentage points; followed by a test for superiority.'}, {'measure': 'Body weight', 'timeFrame': '6, 12 and 24 months', 'description': 'Body weight as a continuous outcome'}, {'measure': 'Achieved weight loss of at least 15 kg', 'timeFrame': '6, 12 and 24 months', 'description': 'Number of participants with achieved weight loss of at least 15 kg'}, {'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', 'description': 'Partial diabetes remission (\\<7.0 mol/l), complete diabetes remission (\\<6.1 mol/l) without diabetes medication.'}, {'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', 'description': 'Measured at the research facilities'}, {'measure': 'Blood pressure', 'timeFrame': '6, 12, 24 months', 'description': '24h monitoring'}, {'measure': 'Plasma lipid profile', 'timeFrame': '6, 12, 24 months'}, {'measure': 'Liver enzymes', 'timeFrame': '6, 12, 24 months', 'description': 'AST, ALT'}, {'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', 'description': 'Three factor eating questionnaire'}, {'measure': 'Estimation of exhaustion', 'timeFrame': '6, 12, 24 months', 'description': 'Karolinska Exhaustion Disorder Scale. Minimum value 0. Maximum value 54. A higher score means a worse outcome.'}, {'measure': 'Quality of life accoring to Brunnsviken Brief Quality of Life Scale', 'timeFrame': '6, 12, 24 months', 'description': 'The scale estimates how satisfied the participants is with different areas of life, as well as how important each area of life is. Minimum scale 0. Maximum scale 48. A higher score means a better outcome.'}, {'measure': 'Quality of life according to EQ-5D-5L', 'timeFrame': '6, 12, 24 months', 'description': 'The questionnaire investigates the dimensions mobility, self-care, usual activities, pain and anxiety/depression. Minimum value 1. Maximum value 5. A higher score means a worse outcome. In addition, a general health score is assessed. Minimum value 0. Maximum value 100. A higher score means a better outcome. All dimension will be analysed separately, but EQ-5D-5L will also be combined to one score.'}, {'measure': 'Eating habits', 'timeFrame': '6, 12, 24 months', 'description': 'FFQ 2020 questionnaire'}, {'measure': 'Estimation of health', 'timeFrame': '6, 12, 24 months', 'description': 'SF-36 questionnaire'}, {'measure': 'Daily steps', 'timeFrame': '6, 12, 24 months', 'description': 'Measured with activity tracker'}, {'measure': 'Study experience', 'timeFrame': '24 months', 'description': 'Qualitative questions with written answers about study experience'}, {'measure': 'HbA1c follow-up', 'timeFrame': 'Yearly up to 20 years', 'description': 'Collected from patient journals after study completion'}, {'measure': 'Body weight follow-up', 'timeFrame': 'Yearly up to 20 years', 'description': 'Collected from patient journals after study completion'}, {'measure': 'Blood pressure follow-up', 'timeFrame': 'Yearly up to 20 years', 'description': 'Collected from patient journals after study completion'}, {'measure': 'Usage of diabetes medication follow-up', 'timeFrame': 'Yearly up to 20 years', 'description': 'Collected from patient journals after study completion'}, {'measure': 'Usage of hypertension medication follow-up', 'timeFrame': 'Yearly up to 20 years', 'description': 'Collected from patient journals after study completion'}, {'measure': 'Diabetes complications follow-up', 'timeFrame': 'Yearly up to 20 years', 'description': 'Collected from patient journals and registries after study completion'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['Diabetes Remission', 'Nutrition Therapy', 'Obesity', 'eHealth', 'Weight Loss'], 'conditions': ['Diabetes Mellitus, Type 2']}, 'referencesModule': {'references': [{'pmid': '32598218', 'type': 'BACKGROUND', '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.'}, {'pmid': '40701606', 'type': 'DERIVED', 'citation': '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.'}]}, 'descriptionModule': {'briefSummary': '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.', 'detailedDescription': '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.\n\nThe 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).\n\neHealth group:\n\nAll 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.\n\nFace-to-face group:\n\nParticipants 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.\n\nHealthy control group:\n\nFifteen 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.\n\nOutcomes:\n\nPrimary 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.\n\nLong-term follow-up:\n\nBecause 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.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '70 Years', 'minimumAge': '20 Years', 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Type 2 diabetes with duration 0-6 years\n* BMI 27 kg/m2 and higher\n* HbA1c 43 mmol/mol or higher (48 or higher if without diabetes medication)\n\nExclusion Criteria:\n\n* Insulin treatment\n* Weight loss more than 5 kg during the past 6 months\n* Diagnosed eating disorder\n* eGFR \\< 30 ml/min/1,73m2\n* Myocardial infarction last six months\n* Severe heart failure (NYHA class III)\n* Ongoing cancer\n* Pregnancy\n* Treatment with antipsychotic drugs'}, 'identificationModule': {'nctId': 'NCT05491005', 'acronym': 'eDIT', 'briefTitle': 'The eHealth Diabetes Remission Trial', 'organization': {'class': 'OTHER', 'fullName': 'Umeå University'}, 'officialTitle': 'eHealth Diabetes Remission Trial (Swedish: Remission av Typ 2 Diabetes Med hjälp av eHälsa', 'orgStudyIdInfo': {'id': 'Dnr 2022-02242-01'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'eHealth', 'interventionNames': ['Behavioral: Total diet replacement', 'Behavioral: eHealth']}, {'type': 'EXPERIMENTAL', 'label': 'Face-to-face', 'interventionNames': ['Behavioral: Total diet replacement', 'Behavioral: Face-to-face']}, {'type': 'NO_INTERVENTION', 'label': 'Healthy control group'}], 'interventions': [{'name': 'Total diet replacement', 'type': 'BEHAVIORAL', 'description': 'Total diet replacement (850 kcal/day) for 3 months followed by weight maintenance for 21 months.', 'armGroupLabels': ['Face-to-face', 'eHealth']}, {'name': 'eHealth', 'type': 'BEHAVIORAL', 'description': 'All follow-up through an eHealth application and video meetings.', 'armGroupLabels': ['eHealth']}, {'name': 'Face-to-face', 'type': 'BEHAVIORAL', 'description': 'All follow-up through face-to-face meetings.', 'armGroupLabels': ['Face-to-face']}]}, 'contactsLocationsModule': {'locations': [{'city': 'Jönköping', 'status': 'RECRUITING', 'country': 'Sweden', 'contacts': [{'name': 'Andreas Stomby, PhD', 'role': 'CONTACT'}], 'facility': 'Bra Liv Råslätt vårdcentral', 'geoPoint': {'lat': 57.78145, 'lon': 14.15618}}, {'city': 'Örnsköldsvik', 'status': 'NOT_YET_RECRUITING', 'country': 'Sweden', 'contacts': [{'name': 'Katarina Shahedi, MD', 'role': 'CONTACT'}], 'facility': 'Örnsköldsvik hospital', 'geoPoint': {'lat': 63.29091, 'lon': 18.71525}}, {'zip': '90187', 'city': 'Umeå', 'status': 'RECRUITING', 'country': 'Sweden', 'contacts': [{'name': 'Julia Otten, MD, PhD', 'role': 'CONTACT'}, {'name': 'Julia Otten, MD, PhD', 'role': 'PRINCIPAL_INVESTIGATOR'}], 'facility': 'Department of Public Health and Clinical Medicine, Medicine', 'geoPoint': {'lat': 63.82842, 'lon': 20.25972}}], 'centralContacts': [{'name': 'Julia Otten, PhD', 'role': 'CONTACT', 'email': 'julia.otten@umu.se', 'phone': '+46703341559'}], 'overallOfficials': [{'name': 'Julia Otten, PhD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Umeå University'}]}, 'ipdSharingStatementModule': {'infoTypes': ['STUDY_PROTOCOL', 'SAP', 'CSR', 'ANALYTIC_CODE'], 'timeFrame': 'Data is available to other researchers as soon as it is published.', 'ipdSharing': 'YES', 'description': 'Data will be shared with other researchers on reasonable request.', 'accessCriteria': 'Data will be shared with other researchers on reasonable request.'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Umeå University', 'class': 'OTHER'}, 'collaborators': [{'name': 'Region Västerbotten', 'class': 'OTHER_GOV'}, {'name': 'Edgar Sjölunds Diabetes Foundation', 'class': 'UNKNOWN'}], 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Principal investigator', 'investigatorFullName': 'Julia Otten', 'investigatorAffiliation': 'Umeå University'}}}}