Effectiveness of complementary integrative therapy with fasting in patients with diabetes mellitus type 2 and metabolic syndrome: A randomized controlled pilot study.
- Conditions
- E88.9E11.90Metabolic disorder, unspecified
- Registration Number
- DRKS00004715
- Lead Sponsor
- Abteilung für Naturheilkunde der Charité im Immanuel-Krankenhaus Berlin-Wannsee
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Recruiting
- Sex
- All
- Target Recruitment
- 40
1.A signed consent form
2.Age 25 - 70 years
3.Existence of a specialist secure type 2 diabetes mellitus (HbA1c> 7%)
4.Maximum basal insulin 40 IU
5.BMI > 25Kg/cm ²
6.Waist cm men > 94, women > 80 cm
7.Patient is intellectually and linguistically able to understand the significance of the study
1.Pregnancy, lactation period
2.Diabetes mellitus type-1 with basal-bolus insulin therapy
3.Lack of insulin C-peptide> 1.2 ng / dl
4.Hypotension <100/60 mmHg
5.Myocardial infarction, pulmonary embolism or stroke in the three last months
6.Renal insufficiency stage III
7.Heart failure NYHA stage III
8.Diabetic retinopathy
9.PAOD stage> 2b
10.Diabetic foot syndrome > Wagner 1, A Armstrong
11.Manifest eating disorder or binge-eating disorder
12.Serious acute somatic disease or infectious disease
13.Severe or acute mental illness
14.Simultaneous participation in another study
Study & Design
- Study Type
- interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Change in long-term blood sugar (HbA1c) using a blood collection: baseline (day 0) versus endpoint (12 weeks).
- Secondary Outcome Measures
Name Time Method - HOMA score for insulin sensitivity<br>- Quality of Life (WHO-5)<br>- Overall assessment of efficacy and tolerability (Likert scale) by the patient<br>- Weight, abdominal girth<br>- HbA1 C, glucose and insulin levels<br>- Blood pressure, systolic / diastolic <br>- Blood lipids (Chol LDL-C, HDL-C, TG): baseline (day 0) versus endpoint (12 weeks).<br><br>