Effects of an Amino Acid and Chromium-picolinate Containing Drink on Glucose Metabolism

Study Overview
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Brief Summary
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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.

Official Title
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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

Conditions
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Type 2 Diabetes, Prediabetes

Intervention / Treatment
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* Dietary Supplement: Amino Acid and chromium-picolinate containing drink
* Dietary Supplement: Placebo Drink


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 70 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Supportive Care
Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: Quadruple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: Amino Acids, Chromium - Picolinate<br>Verum drink containing the dietary supplements is taken with a test meal. INsulin and glucose response is documented for 180 minutes. | Dietary Supplement: Amino Acid and chromium-picolinate containing drink<br>* Amino Acid and chromium - picolinate containg water ist taken with a test meal to study efects on glucose and insulin response.<br>Dietary Supplement: Placebo Drink<br>* Placebo drink ist taken with a test meal to study efects on glucose and insulin response.<br>|
| Placebo Comparator: Placebo Drink<br>Placebo Drink containing aroma only is taken with a test meal. INsulin and glucose response is documented for 180 minutes. | Dietary Supplement: Amino Acid and chromium-picolinate containing drink<br>* Amino Acid and chromium - picolinate containg water ist taken with a test meal to study efects on glucose and insulin response.<br>Dietary Supplement: Placebo Drink<br>* Placebo drink ist taken with a test meal to study efects on glucose and insulin response.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Area under the curve for Glucose | Area under the curve for glucose will be measured within 180 minutes after a test meal. Blood samples will be drawan at 8 timepoints during 180 minutes after ingestion of the test meal (0', 15', 30', 60', 90', 120', 150', 180'). | 0', 15', 30', 60', 90', 120', 150', 180' post test meal | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| AUC for insulin | Blood samples will be drawan at 8 timepoints during 180 minutes after ingestion of the test meal (0', 15', 30', 60', 90', 120', 150', 180'). | 0', 15', 30', 60', 90', 120', 150', 180' post test meal | 
| Markers of inflammation | Blood samples will be drawan at 8 timepoints during 180 minutes after ingestion of the test meal (0', 15', 30', 60', 90', 120', 150', 180'). At these timepoints markers of inflammation will be measured (i.e. hsCRP and others) | at 0', 15', 30', 60', 90', 120', 150', 180' post test meal | 
| markers of lipid metabolism | Triglycerides, VLDL and other parameters of lipid metabolism are planned to be measured within 180 minutes after a test meal at 0', 15', 30', 60', 90', 120', 150', 180'. | 0', 15', 30', 60', 90', 120', 150', 180' post test meal | 
| Gut peptide hormones | Area under the curve for GLP-1, ghrelin, glucagone and GIP are measured within 180 minutes after the test meal. | 0', 15', 30', 60', 90', 120', 150', 180' post test meal |