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

September 20, 2019 updated by: Dr. Per Humpert, Stoffwechselzentrum Rhein - Pfalz

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

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

20

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Germany
      • Mannheim, Germany, 68163
        • Stoffwechselzentrum Rhein Pfalz

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 70 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Supportive Care
  • Allocation: Randomized
  • Interventional Model: Crossover Assignment
  • Masking: Quadruple

Arms and Interventions

Participant Group / 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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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').
0', 15', 30', 60', 90', 120', 150', 180' post test meal

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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').
0', 15', 30', 60', 90', 120', 150', 180' post test meal
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)
at 0', 15', 30', 60', 90', 120', 150', 180' post test meal
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'.
0', 15', 30', 60', 90', 120', 150', 180' post test meal
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.
0', 15', 30', 60', 90', 120', 150', 180' post test meal

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Stoffwechselzentrum Rhein - Pfalz

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

August 1, 2014

Primary Completion (Actual)

November 1, 2015

Study Completion (Actual)

November 1, 2015

Study Registration Dates

First Submitted

August 28, 2014

First Submitted That Met QC Criteria

September 5, 2014

First Posted (Estimate)

September 9, 2014

Study Record Updates

Last Update Posted (Actual)

September 24, 2019

Last Update Submitted That Met QC Criteria

September 20, 2019

Last Verified

September 1, 2019

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • SWZRP-14-01

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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