Prediabetes, Type 2 Diabetes
Conditions
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.
Interventions
DIETARY_SUPPLEMENTAmino 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_SUPPLEMENTPlacebo Drink
Placebo drink ist taken with a test meal to study efects on glucose and insulin response.
Sponsors
Stoffwechselzentrum Rhein - Pfalz
Study design
Allocation
RANDOMIZED
Intervention model
CROSSOVER
Primary purpose
SUPPORTIVE_CARE
Masking
QUADRUPLE (Subject, Caregiver, Investigator, Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
18 Years to 70 Years
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| 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
| Measure | Time frame | Description |
|---|---|---|
| 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) |
| 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. |
Countries
Germany
Outcome results
None listed