Effects of an Amino Acid and Chromium-picolinate Containing Drink on Glucose Metabolism
- Conditions
- Type 2 DiabetesPrediabetes
- Interventions
- Dietary Supplement: Amino Acid and chromium-picolinate containing drinkDietary Supplement: Placebo Drink
- Registration Number
- NCT02235194
- Lead Sponsor
- Stoffwechselzentrum Rhein - Pfalz
- Brief Summary
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.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 20
- 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
Not provided
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- CROSSOVER
- Arm && Interventions
Group Intervention Description Amino Acids, Chromium - Picolinate Amino Acid and chromium-picolinate containing drink Verum drink containing the dietary supplements is taken with a test meal. INsulin and glucose response is documented for 180 minutes. Placebo Drink Placebo Drink Placebo Drink containing aroma only is taken with a test meal. INsulin and glucose response is documented for 180 minutes. Placebo Drink Amino Acid and chromium-picolinate containing drink Placebo Drink containing aroma only is taken with a test meal. INsulin and glucose response is documented for 180 minutes. Amino Acids, Chromium - Picolinate Placebo Drink Verum drink containing the dietary supplements is taken with a test meal. INsulin and glucose response is documented for 180 minutes.
- Primary Outcome Measures
Name Time Method Area under the curve for Glucose 0', 15', 30', 60', 90', 120', 150', 180' post test meal 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').
- Secondary Outcome Measures
Name Time Method markers of lipid metabolism 0', 15', 30', 60', 90', 120', 150', 180' post test meal 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'.
Gut peptide hormones 0', 15', 30', 60', 90', 120', 150', 180' post test meal Area under the curve for GLP-1, ghrelin, glucagone and GIP are measured within 180 minutes after the test meal.
AUC for insulin 0', 15', 30', 60', 90', 120', 150', 180' post 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').
Markers of inflammation at 0', 15', 30', 60', 90', 120', 150', 180' post 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'). At these timepoints markers of inflammation will be measured (i.e. hsCRP and others)
Trial Locations
- Locations (1)
Stoffwechselzentrum Rhein Pfalz
🇩🇪Mannheim, Germany