Trial document





This trial has been registered retrospectively.
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  DRKS00003111

Trial Description

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Title

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

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Trial Acronym

[---]*

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URL of the Trial

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Brief Summary in Lay Language

Dietary supplements may be a supporting therapy for patients with diabetes mellitus. Several micronutrients such as zinc and chromium were able to show positive effects on blood glucose regulation.Regulat® Spezial Diabetic is a dietary supplement which combines those micronutrients with plant extracts which are extracted by cascade fermentation in order to lower blood glucose levels. Aim of the study is to test the blood glucose lowering effect in patients with type 2 diabetes mellitus (without insulin treatment). Patients are asked to take 10ml Regulat® Spezial Diabetic or placebo twice a day before breakfast and dinner respectively over a period of 12 weeks. After a wash-out of 12 weeks patients are assigned to the other product (Regulat® Spezial Diabetic or placebo) also taken twice a day for 12 weeks. Main focus is on the HbA1c, fructosamine and fasting blood glucose.

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Brief Summary in Scientific Language

Dietary supplements may be a supporting therapy for patients with diabetes mellitus. Several micronutrients such as zinc and chromium were able to show positive effects on blood glucose regulation. Regulat® Spezial Diabetic is a dietary supplement which combines those micronutrients with plant extracts which are extracted by cascade fermentation in order to lower blood glucose levels. Aim of this placebo-controled, randomised study in a cross-over-design is to test the blood glucose lowering effect in patients with type 2 diabetes mellitus (without insulin treatment). Patients are asked to take 10ml Regulat® Spezial Diabetic or placebo twice a day before breakfast and dinner respectively over a period of 12 weeks. After a wash-out of 12 weeks patients are assigned to the other product (Regulat® Spezial Diabetic or placebo) also taken twice a day for 12 weeks. Main focus is on the HbA1c, fructosamine and fasting blood glucose.

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Organizational Data

  •   DRKS00003111
  •   2011/07/18
  •   [---]*
  •   no
  •   Approved
  •   2866/10, Ethik-Kommission der Fakultät für Medizin der Technischen Universität München
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Secondary IDs

  • [---]*
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Health Condition or Problem studied

  •   E11 -  Non-insulin-dependent diabetes mellitus
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Interventions/Observational Groups

  •   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.
  •   Regulat® Spezial Diabetic: Regulat® Spezial Diabetic 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.
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Characteristics

  •   Interventional
  •   [---]*
  •   Randomized controlled trial
  •   Blinded
  •   patient/subject, investigator/therapist, data analyst
  •   Placebo
  •   Treatment
  •   Crossover
  •   N/A
  •   [---]*
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Primary Outcome

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

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Secondary Outcome

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.

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Countries of Recruitment

  •   Germany
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Locations of Recruitment

  • [---]*
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Recruitment

  •   Actual
  •   2010/10/28
  •   35
  •   Monocenter trial
  •   National
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Inclusion Criteria

  •   Both, male and female
  •   25   Years
  •   73   Years
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Additional 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

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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

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Addresses

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    • Else Kröner-Fresenius-Zentrum für Ernährungsmedizin der TU München Lehrtsuhl für Ernährungsmedizin
    • Mr.  Prof. Dr. med.  Hans  Hauner 
    • Gregor-Mendel-Str. 2
    • 85350  Freising
    • Germany
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    • Else Kröner-Fresenius-Zentrum für Ernährungsmedizin der TU München Lerhrstuhl für Ernährungsmedizin
    • Mr.  Prof.Dr.med.  Hans   Hauner 
    • Gregor-Mendel-Str. 2
    • 85350  Freising-Weihenstephan
    • Germany
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    • Else Kröner-Fresenius-Zentrum für Ernährungsmedizin der TU München Lehrstuhl für Ernährungsmedizin
    • Mr.  PD Dr.med.  Thomas  Skurk 
    • Gregor-Mednel-Str. 2
    • 85350  Freising-Weihenstephan
    • Germany
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Sources of Monetary or Material Support

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    • Dr. Niedermaier Pharma GmbH
    • Taufkirchner Str. 59
    • 85662  Hohenbrunn
    • Germany
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Status

  •   Recruiting complete, follow-up complete
  •   2012/03/09
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* This entry means the parameter is not applicable or has not been set.