Effects of Regulat® Spezial Diabetic on metabolic control in patients with type 2 diabetes mellitus

Not Applicable

• Conditions: E11; Type 2 diabetes mellitus

• Registration Number: DRKS00003111
• Lead Sponsor: Else Kröner-Fresenius-Zentrum für Ernährungsmedizin der TU München Lehrtsuhl für Ernährungsmedizin

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Study Start: 2011-07-18
• Study Completion: 2012-03-09
• Last Update Posted: 19 August 2024

Recruitment & Eligibility

• Status: Complete
• Sex: All
• Target Recruitment: 35

Inclusion Criteria

Diabetes mellitusType 2 at least for 1 year,HbA1c > 6,5 und < 10,0%, stable metabolic control for 3 months prior to study entry, BMI 25-40 kg/m2, stable body weight (+/- 2kg in the last 3 months), written informed consent

Exclusion Criteria

insulin treatment; known allergies to nuts, citrus fruits, dates, soja, coconut, sellerie, oranges; uncontrolled arterial hypertension (= 160/95 mmHg); instable coronary heart disease; psychiatric diseases; serious illness

Study & Design

• Study Type: interventional
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
The HbA1c is measured in the blood at the beginning and the end of the treatment period of 12 weeks.

Secondary Outcome Measures

Name	Time	Method
Fructosamine, hsCRP, HMW-adiponectin, uric acid, chromium in plasma,and zinc in plasma are measured in the blood at the beginning and the end of the treatment period of 12 weeks.<br>Total cholesterol, HDL-cholesterol, LDL-cholesterol, triglycerides, fasting blood glucose, insulin, GOT, GPT, gGT are measured in the blood at week 0, 4, and 12. Bodyweight and blood pressure are measured at week 0, 4, and 12.