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

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

Status
Active, not recruiting
Phases
Unknown
Study type
Interventional
Source
DRKS
Registry ID
DRKS00003111
Enrollment
35
Registered
2011-07-18
Start date
2010-10-28
Completion date
Unknown
Last updated
2025-04-07

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

E11

Interventions

Group 1: Placebo: Placebo is given out in 20ml bottles. Patients are asked to take 10ml ( one table spoon) of the fluid twice a day before breakfast and dinner respectively over a period of 12 weeks.

Sponsors

Else Kröner-Fresenius-Zentrum für Ernährungsmedizin der TU München Lehrtsuhl für Ernährungsmedizin
Lead Sponsor

Eligibility

Sex/Gender
All
Age
25 Years to 73 Years

Inclusion criteria

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

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

Design outcomes

Primary

MeasureTime frame
The HbA1c is measured in the blood at the beginning and the end of the treatment period of 12 weeks.

Secondary

MeasureTime frame
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. 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.

Countries

Germany

Contacts

Public ContactThomas Skurk

Else Kröner-Fresenius-Zentrum für Ernährungsmedizin der TU München Lehrstuhl für Ernährungsmedizin

skurk@wzw.tum.de08161-712007

Outcome results

None listed

Source: DRKS (via WHO ICTRP) · Data processed: Feb 4, 2026