Effects of whole-body electromyostimulation training on glycaemia and physical performance in adults with double diabetes

Not Applicable

Conditions: Double Diabetes (ICD10, E13)
E13
Other specified diabetes mellitus

Registration Number: DRKS00034560

Lead Sponsor: Institut für Radiologie, Universitätsklinikum Erlangen, Deutschland

Brief Summary: Not available

Detailed Description: Not available

Recruitment & Eligibility

Status: Pending

Sex: All

Target Recruitment: 48

Inclusion Criteria

Legally competent men and women with clinically manifest T1DM
At least one additional criterion of metabolic syndrome according to the International Diabetes Federation, i.e.
Abdominal circumference =94 cm (men) or =80 cm (women)
Triglyceride values =150 mg/dl or treatment already initiated
HDL cholesterol <40 mg/dl (men) <50 mg/dl (women) or therapy
High blood pressure (systolic =130, diastolic =85 mmHg) or therapy
Overweight (BMI =25.0 kg/m2)
HbA1c >6.5%

Exclusion Criteria

Cardiovascular diseases, in particular high-grade cardiac arrhythmia / atrial fibrillation / pacemaker or heart failure > NYHA1
High-grade (drug-treated) obstructive and restrictive lung disease (asthma / COPD / PHT)
epilepsy
Severe circulatory disordersGFR<60; diabetic nephropathy
Regular (= 1TE/week) strength training in the last 8 weeks
Contraindications for the use of MRI
Absolute contraindications for WB-EMS
Anticipated absence = 3 weeks during the intervention period

Study & Design

Study Type: interventional

Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Time in Range (TIR; Glucose 70-180 mg/d),<br>baseline assessment (before the intervention) and 4-month control assessment (4-month FU)

Secondary Outcome Measures

Name	Time	Method
Time below the target range (TBR; <70 mg/dL), at baseline and 4 month FU<br>Time above the target range (TAR; >180 mg/dL), at baseline and 4 month FU<br>Fasting glucose, insulin, cortisol, triglycerides, total-, HDL-, LDL-cholesterol, at baseline and 4 month FU <br>Resting blood pressure (MAP), at baseline and 4 month FU<br>Total and regional body fat mass, at baseline and 4 month FU<br>Total and regional lean body mass, at baseline and 4 month FU<br>Visceral fat volume, at baseline and 4 month FU<br>intramuscular fat accumulation (intramuscular adipose tissue: IMAT), at baseline and 4 month FU<br>Isokinetic maximum strength of the hip-/leg extensors, isom. trunk strength, at baseline and 4 month FU<br>Endurance capacity, at baseline and 4 month FU<br>Resting metabolic rate, at baseline and 4 month FU<br>Attendance, drop-out, withdrawals, continuously during the intervention<br>Adverse events, serious adverse events, continuously during the intervention