Diabetes Mellitus, Type 2 Clinical Trial
— eDITOfficial title:
eHealth Diabetes Remission Trial (Swedish: Remission av Typ 2 Diabetes Med hjälp av eHälsa
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.
Status | Recruiting |
Enrollment | 106 |
Est. completion date | December 31, 2026 |
Est. primary completion date | December 31, 2026 |
Accepts healthy volunteers | Accepts Healthy Volunteers |
Gender | All |
Age group | 20 Years to 70 Years |
Eligibility | 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 |
Country | Name | City | State |
---|---|---|---|
Sweden | Bra Liv Råslätt vårdcentral | Jönköping | |
Sweden | Örnsköldsvik hospital | Örnsköldsvik | |
Sweden | Department of Public Health and Clinical Medicine, Medicine | Umeå |
Lead Sponsor | Collaborator |
---|---|
Umeå University | Edgar Sjölunds Diabetes Foundation, Region Västerbotten |
Sweden,
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. — View Citation
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Other | Insulin sensitivity | Hyperinsulinemic euglycemic clamp | 12 months | |
Other | Insulin secretion | Stepped insulin secretion test with arginine | 12 months | |
Other | Metabolic flexibility | Hyperinsulinemic euglycemic clamp | 12 months | |
Other | Resting metabolic rate | Indirect calorimetry | 12 months | |
Other | Body composition | Dual-energy X-ray absorptiometry (DXA). | 12 months | |
Other | Glucagon sensitivity | Plasma amino acids are measured during 120 minutes after a intravenous glucagon bolus | 12 months | |
Other | Amino acid tolerance | Plasma amino acids are measured during intravenous amino acid infusion | 12 months | |
Other | Glucagon secretion capacity | Plasma glucagon is measured during intravenous amino acid infusion | 12 months | |
Other | Gut hormones after carbohydrate intake | GLP-1, GIP and gherkin during the oral glucose tolerance test | 6, 12, 24 months | |
Other | P-metabolites and P-lipids after carbohydrate intake | Metabolomics and lipidomics analyses during the oral glucose tolerance test | 6, 12, 24 months | |
Other | Liver fat | Measured with MRI | 12 months | |
Other | Pancreas fat | Measured with MRI | 12 months | |
Other | Fat cell size in subcutaneous fat | 12 months | ||
Other | RNA levels in subcutaneous fat | RNA sequencing | 12 months | |
Other | Secretion of adipokines, metabolites and lipids in subcutaneous fat cells ex vivo | 12 months | ||
Other | Plasma testosterone levels | Only men | 6, 12 and 24 months | |
Other | Erectile function | Only men, Erectile function subscale | 6, 12, 24 months | |
Other | Prostate symptoms | Only men, International prostate symptom score | 6, 12, 24 months | |
Other | Urine albumin to creatinine ratio | 6, 12, 24 months | ||
Other | Slow vital capacity (SVC) | Spirometry | 12 months | |
Other | Forced vital capacity (FVC) | Spirometry | 12 months | |
Other | Forced expiratory volume in 1 s (FEV1) | Spirometry | 12 months | |
Other | Diffusion capacity of the the (DCLO) | Spirometry | 12 months | |
Other | Troponin T | 6, 12 and 24 months | ||
Other | proBNP | 6, 12 and 24 months | ||
Primary | HbA1c | 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. | 12 months | |
Secondary | HbA1c | 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. | 6 and 24 months | |
Secondary | Diabetes remission | 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. | 6, 12 and 24 months | |
Secondary | Body weight | Body weight as a continuous outcome | 6, 12 and 24 months | |
Secondary | Achieved weight loss of at least 15 kg | Number of participants with achieved weight loss of at least 15 kg | 6, 12 and 24 months | |
Secondary | Incremental costs per diabetes remission | 24 months | ||
Secondary | Estimated lifetime costs | 24 months | ||
Secondary | Estimated lifetime costs per quality-adjusted life-year (QALY) | 24 months | ||
Secondary | Fasting blood glucose | Partial diabetes remission (<7.0 mol/l), complete diabetes remission (<6.1 mol/l) without diabetes medication. | 6, 12, 24 months | |
Secondary | P-glucose 120 minutes after the oral glucose tolerance test | 6, 12, 24 months | ||
Secondary | Number of prescribed oral anti diabetic medications | 6, 12, 24 months | ||
Secondary | Number of prescribed antihypertensive medications | 6, 12, 24 months | ||
Secondary | Blood pressure (systolic/diastolic) | Measured at the research facilities | 6, 12, 24 months | |
Secondary | Blood pressure | 24h monitoring | 6, 12, 24 months | |
Secondary | Plasma lipid profile | 6, 12, 24 months | ||
Secondary | Liver enzymes | AST, ALT | 6, 12, 24 months | |
Secondary | Number of participants that discontinue the intervention | 6, 12, 24 months | ||
Secondary | Waist circumference | 6, 12, 24 months | ||
Secondary | Relation to food | Three factor eating questionnaire | 6, 12, 24 months | |
Secondary | Estimation of exhaustion | Karolinska Exhaustion Disorder Scale. Minimum value 0. Maximum value 54. A higher score means a worse outcome. | 6, 12, 24 months | |
Secondary | Quality of life accoring to Brunnsviken Brief Quality of Life Scale | 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. | 6, 12, 24 months | |
Secondary | Quality of life according to EQ-5D-5L | 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. | 6, 12, 24 months | |
Secondary | Eating habits | FFQ 2020 questionnaire | 6, 12, 24 months | |
Secondary | Estimation of health | SF-36 questionnaire | 6, 12, 24 months | |
Secondary | Daily steps | Measured with activity tracker | 6, 12, 24 months | |
Secondary | Study experience | Qualitative questions with written answers about study experience | 24 months | |
Secondary | HbA1c follow-up | Collected from patient journals after study completion | Yearly up to 20 years | |
Secondary | Body weight follow-up | Collected from patient journals after study completion | Yearly up to 20 years | |
Secondary | Blood pressure follow-up | Collected from patient journals after study completion | Yearly up to 20 years | |
Secondary | Usage of diabetes medication follow-up | Collected from patient journals after study completion | Yearly up to 20 years | |
Secondary | Usage of hypertension medication follow-up | Collected from patient journals after study completion | Yearly up to 20 years | |
Secondary | Diabetes complications follow-up | Collected from patient journals and registries after study completion | Yearly up to 20 years |
Status | Clinical Trial | Phase | |
---|---|---|---|
Active, not recruiting |
NCT05666479 -
CGM Monitoring in T2DM Patients Undergoing Orthopaedic Replacement Surgery
|
||
Completed |
NCT05647083 -
The Effect of Massage on Diabetic Parameters
|
N/A | |
Active, not recruiting |
NCT05661799 -
Persistence of Physical Activity in People With Type 2 Diabetes Over Time.
|
N/A | |
Completed |
NCT03686722 -
Effect of Co-administration of Metformin and Daclatasvir on the Pharmacokinetis and Pharmacodynamics of Metformin
|
Phase 1 | |
Completed |
NCT02836704 -
Comparison of Standard vs Higher Starting Dose of Insulin Glargine in Chinese Patients With Type 2 Diabetes (Glargine Starting Dose)
|
Phase 4 | |
Completed |
NCT01819129 -
Efficacy and Safety of FIAsp Compared to Insulin Aspart in Combination With Insulin Glargine and Metformin in Adults With Type 2 Diabetes
|
Phase 3 | |
Completed |
NCT04562714 -
Impact of Flash Glucose Monitoring in People With Type 2 Diabetes Using Non-Insulin Antihyperglycemic Therapy
|
N/A | |
Completed |
NCT02009488 -
Treatment Differences Between Canagliflozin and Placebo in Insulin Secretion in Subjects With Type 2 Diabetes Mellitus (T2DM)
|
Phase 1 | |
Completed |
NCT05896319 -
Hyaluronic Acid Treatment of the Post-extraction Tooth Socket Healing in Subjects With Diabetes Mellitus Type 2
|
N/A | |
Recruiting |
NCT05598203 -
Effect of Nutrition Education Groups in the Treatment of Patients With Type 2 Diabetes
|
N/A | |
Completed |
NCT05046873 -
A Research Study Looking Into Blood Levels of Semaglutide and NNC0480-0389 When Given in the Same Injection or in Two Separate Injections in Healthy People
|
Phase 1 | |
Completed |
NCT04030091 -
Pulsatile Insulin Infusion Therapy in Patients With Type 1 and Type 2 Diabetes Mellitus
|
Phase 4 | |
Terminated |
NCT04090242 -
Impact of App Based Diabetes Training Program in Conjunction With the BD Nano Pen Needle in People With T2 Diabetes
|
N/A | |
Completed |
NCT03604224 -
A Study to Observe Clinical Effectiveness of Canagliflozin 300 mg Containing Treatment Regimens in Indian Type 2 Diabetes Participants With BMI>25 kg/m^2, in Real World Clinical Setting
|
||
Completed |
NCT03620357 -
Continuous Glucose Monitoring & Management In Type 2 Diabetes (T2D)
|
N/A | |
Completed |
NCT01696266 -
An International Survey on Hypoglycaemia Among Insulin-treated Patients With Diabetes
|
||
Completed |
NCT03620890 -
Detemir Versus NPH for Type 2 Diabetes Mellitus in Pregnancy
|
Phase 4 | |
Withdrawn |
NCT05473286 -
A Research Study Looking at How Oral Semaglutide Works in People With Type 2 Diabetes in Germany, as Part of Local Clinical Practice
|
||
Not yet recruiting |
NCT05029804 -
Effect of Walking Exercise Training on Adherence to Disease Management and Metabolic Control in Diabetes
|
N/A | |
Completed |
NCT04531631 -
Effects of Dorzagliatin on 1st Phase Insulin and Beta-cell Glucose Sensitivity in T2D and Monogenic Diabetes
|
Phase 2 |