Diabetes mellitus type 2
Conditions
Interventions
An extensive eSupported lifestyle program is offered, which combines coach
sessions with electronic dashboarding and self-management, plus electronic
health tips and a digital health quiz game. Inte
Sponsors
Leids Universitair Medisch Centrum
Eligibility
Age
18 Years to 99 Years
Inclusion criteria
Inclusion criteria: Insulin-dependent Type 2 Diabetes Mellitus patients. The goal is to include at least 6 of the 12 patients with kidney damage, with eGFR 2,5 mg/mmol (men) or 3,5 mg/mmol (women).
Exclusion criteria
Exclusion criteria: • Recent ( 170 mmHg and/or DBP > 100 mmHg, 2 out of 3 measurements) • Any chronic disease other than type 2 diabetes hampering participation (at the discretion of the investigator) • Low motivation to participate (score 2 *weak* or 1 *very weak* on a 5-point scale). • Alcohol consumption of more than 28 units per week at present or in the past • Psychiatric disease (as defined by DSM-V) • Claustrophobia, metal implants or other contraindications for cardiac MRI
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main study parameter/endpoint • Feasibility and sustainability of the proposed healthy lifestyle behaviors, measured with 24-hour recall dietary diary, plus validated self-report on physical activity and stress management activities (Ornish 1998). • Attractiveness of the eSupport Lifestyle Intervention, measured via patient satisfaction and the Technology Acceptance Model (TAM; Szajna 1996) on weeks 4, 12, 50. | — |
Secondary
| Measure | Time frame |
|---|---|
| Secondary study parameters/endpoints • Quality of Life (SF-8) • Exercise capability (aerobic & resistance tests, see below) • Fasting plasma glucose, fasting plasma insulin, HbA1C, total cholesterol, HDL cholesterol and triglyceride levels • Blood pressure, BMI, waist circumference • Kidney function: MDRD • Albuminuria: Albumin/Creatinin Ratio. • Medication requirements (insulin, metformin, statins, antihypertensives) • Pancreas, muscle and liver tissue function as reflected by OGTT based multi-parameter diagnosis (weeks 0, 12, 50). • Liver, pancreas, skeletal muscle, kidney and heart ectopic fat accumulation (weeks 0, 12, 50). • Cardiac function (systolic and diastolic function, pulse wave velocity) (weeks 0, 12, 50). a. Heart function: i. Systolic function: stroke volume, ejection fraction, cardiac output, cardiac index, peak ejection rate. ii. Diastolic function: early peak filling rate (E), early deceleration peak (E dec peak), atrial peak filling rate (A), E/A ratio, peak mitral annulus longitudinal motion (Ea), MR estimate of LV filling pressure (E/Ea) b. Heart dimensions: End diastolic volume, end-systolic volume, LV mass, LV mass index, LVMI/EDVI, percentage scar tissue (weeks 0, 12, 50). c. Aorta and carotid vessel wall imaging: total vessel wall area, average vessel wall thickness, minimum vessel wall thickness, maximum vessel wall thickness, vascular distensibility (weeks 0, 12, 50). d. Body fat distribution: (weeks 0, 12, 50). i. Adipose tissue distribution, visceral and subcutaneous fat volume ii. Pancreatic fat content iii. Epicardial fat volume iv. 1H-MRS of the heart, skeletal muscle, liver and kidney triglyceride content These measurements will be conducted at baseline, after 4 weeks, 12 weeks and at 1 year follow up, with three exceptions: a) the extensive OGTT based multi-parameter diagnosis will not be conducted at week 4; b) for patient satisfaction and eSupport attractiveness (TAM) the first measurement is con | — |
Countries
Netherlands
Outcome results
None listed