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

Stoffwechselzentrum Rhein - Pfalz

Status: Completed

Conditions: Prediabetes; Type 2 Diabetes

Treatments: Dietary Supplement: Amino Acid and chromium-picolinate containing drink; Dietary Supplement: Placebo Drink

Study type: Interventional

Funder types: Other

Identifiers

NCT02235194

SWZRP-14-01

Details and patient eligibility

About

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.

Enrollment: 20 patients

Sex: All

Ages: 18 to 70 years old

Volunteers: No Healthy Volunteers

Inclusion and exclusion 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

Trial design

Primary purpose: Supportive Care

Allocation: Randomized

Interventional model: Crossover Assignment

Masking: Quadruple Blind

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20 participants in 2 patient groups, including a placebo group

Amino Acids, Chromium - Picolinate

Active Comparator group

Description:

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

Treatment:

Dietary Supplement: Placebo Drink

Dietary Supplement: Amino Acid and chromium-picolinate containing drink

Placebo Drink

Placebo Comparator group

Description:

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

Treatment:

Dietary Supplement: Placebo Drink

Dietary Supplement: Amino Acid and chromium-picolinate containing drink