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NCT Number: NCT02235194

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

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.

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Key information

Conditions

Type 2 Diabetes Diabetes Mellitus Diabetes Mellitus, Type 2 Endocrine System Diseases Glucose Metabolism Disorders Metabolic Diseases Nutritional and Metabolic Diseases PreDiabetes Prediabetic State

Age range

18 year–70 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Stoffwechselzentrum Rhein Pfalz

Mannheim, 68163, Germany

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Amino Acid and chromium-picolinate containing drink

Dietary Supplement

Amino Acid and chromium - picolinate containg water ist taken with a test meal to study efects on glucose and insulin response.

Placebo drink

Dietary Supplement

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

Primary outcomes

  1. Area under the curve for Glucose

    Time frame: 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 outcomes

  1. AUC for insulin

    Time frame: 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').

  2. Markers of inflammation

    Time frame: 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)

  3. markers of lipid metabolism

    Time frame: 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'.

  4. Gut peptide hormones

    Time frame: 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.

Sponsors and collaborators

Lead sponsor

Stoffwechselzentrum Rhein - Pfalz

Other

Registry information

Official study 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

Important dates

Study start
2014
Primary completion
2015
Study completion
2015
First posted
Sep 9, 2014
Registry last updated
Sep 24, 2019

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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