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

Type 2 Diabetes Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02235194
• Other study ID #: SWZRP-14-01
• Status: Completed
• Phase: N/A
• Start date: August 2014
• Est. completion date: November 2015

Study information

• Verified date: September 2019
• Source: Stoffwechselzentrum Rhein - Pfalz
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 20
• Est. completion date: November 2015
• Est. primary completion date: November 2015
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 70 Years

Eligibility

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

Related Conditions & MeSH terms

• Diabetes Mellitus, Type 2
• Prediabetes
• Prediabetic State
• Type 2 Diabetes

Intervention

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

Locations

Country	Name	City	State
Germany	Stoffwechselzentrum Rhein Pfalz	Mannheim

Sponsors (1)

Lead Sponsor	Collaborator
Stoffwechselzentrum Rhein - Pfalz

Country where clinical trial is conducted

Germany, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	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
Secondary	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
Secondary	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
Secondary	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