Trial | NCT02235194  Report issue

Title

Effects of an Amino Acid and Chromium-picolinate Containing Drink on Glucose Metabolism
Influence of an Amino Acid and Chromium Containing Table Water on Glucose Response to a Test Meal in Type 2 Diabetes Patients in a Double Blind Cross - Over Design

  • Phase

    N/A

  • Study Type

    Interventional

  • Status

    Completed No Results Posted

  • Study Participants

    20
It has previously been shown in healthy overweight subjects, that table water including a defined amount of amino acids and chromium can decrease the postprandial glucose and insulin response. In this study, the effect of this table water on glucose excursions after a test meal containing a defined amount of available carbohydrates, protein and fat will be studied in patients with early type 2 diabetes or prediabetes according to guidelines that are treated with dietary measures or metformin only. The study will be conducted in a cross -over design, double blinded and placebo controlled including 20 participants. The primary endpoint of the study is the incremental area under the curve for plasma glucose (iAUCgluc) within 180 minutes after ingestion of the meal.
Study Started
Aug 31
2014
Primary Completion
Nov 30
2015
Study Completion
Nov 30
2015
Last Update
Sep 24
2019

Dietary Supplement Amino Acid and chromium-picolinate containing drink

Amino Acid and chromium - picolinate containg water ist taken with a test meal to study efects on glucose and insulin response.

Dietary Supplement Placebo Drink

Placebo drink ist taken with a test meal to study efects on glucose and insulin response.

Amino Acids, Chromium - Picolinate Active Comparator

Verum drink containing the dietary supplements is taken with a test meal. INsulin and glucose response is documented for 180 minutes.

Placebo Drink Placebo Comparator

Placebo Drink containing aroma only is taken with a test meal. INsulin and glucose response is documented for 180 minutes.

Criteria 

Inclusion Criteria:

Early Type 2 Diabetes (i.e. on Metformin or diet only)
Prediabetes (i.e. FPG 100-125 mg/dl or IGT 2h PG in OGTT 140-199 mg/dl)
HbA1c < 7%
BMI 28,0-39,9 kg/m²

Exclusion Criteria

Any antidiabetic medication other than metformin
Psychiatric Disease
Acute Infections
Alcohol or drug abuse
Malignant tumors or hematologic disorders
Heart failure NYHA III-IV
Acute coronary syndrome
Any macrovascular event within previous 3 months
Chronic kidney disease > Stage 3
Pregnancy or Lactation
No Results Posted