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Trial record 14 of 1007 for:    Area Under Curve AND insulin

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

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ClinicalTrials.gov Identifier: NCT02235194
Recruitment Status : Completed
First Posted : September 9, 2014
Last Update Posted : November 17, 2015
Sponsor:
Information provided by (Responsible Party):
Dr. Per Humpert, 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.

Condition or disease Intervention/treatment Phase
Type 2 Diabetes, Prediabetes Dietary Supplement: Amino Acid and chromium-picolinate containing drink Dietary Supplement: Placebo Drink Not Applicable

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 20 participants
Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Supportive Care
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
Study Start Date : August 2014
Actual Primary Completion Date : November 2015
Actual Study Completion Date : November 2015

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Active Comparator: Amino Acids, Chromium - Picolinate
Verum drink containing the dietary supplements is taken with a test meal. INsulin and glucose response is documented for 180 minutes.
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.

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

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

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




Primary Outcome Measures :
  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 Outcome Measures :
  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.



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Ages Eligible for Study:   18 Years to 70 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02235194


Locations
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Germany
Stoffwechselzentrum Rhein Pfalz
Mannheim, Germany, 68163
Sponsors and Collaborators
Stoffwechselzentrum Rhein - Pfalz

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Responsible Party: Dr. Per Humpert, Privatdozent Dr. Per M. Humpert, Stoffwechselzentrum Rhein - Pfalz
ClinicalTrials.gov Identifier: NCT02235194     History of Changes
Other Study ID Numbers: SWZRP-14-01
First Posted: September 9, 2014    Key Record Dates
Last Update Posted: November 17, 2015
Last Verified: November 2015

Additional relevant MeSH terms:
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Insulin
Insulin, Globin Zinc
Diabetes Mellitus, Type 2
Prediabetic State
Diabetes Mellitus
Glucose Metabolism Disorders
Metabolic Diseases
Endocrine System Diseases
Chromium
Picolinic acid
Hypoglycemic Agents
Physiological Effects of Drugs
Trace Elements
Micronutrients
Nutrients
Growth Substances
Iron Chelating Agents
Chelating Agents
Sequestering Agents
Molecular Mechanisms of Pharmacological Action