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

Primary Purpose

Type 2 Diabetes, Prediabetes

Status
Completed
Phase
Not Applicable
Locations
Germany
Study Type
Interventional
Intervention
Amino Acid and chromium-picolinate containing drink
Placebo Drink
Sponsored by
Stoffwechselzentrum Rhein - Pfalz
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional supportive care trial for Type 2 Diabetes

Eligibility Criteria

18 Years - 70 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • Stoffwechselzentrum Rhein Pfalz

Arms of the Study

Arm 1

Arm 2

Arm Type

Active Comparator

Placebo Comparator

Arm Label

Amino Acids, Chromium - Picolinate

Placebo Drink

Arm Description

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

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

Outcomes

Primary Outcome Measures

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').

Secondary Outcome Measures

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').
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)
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'.
Gut peptide hormones
Area under the curve for GLP-1, ghrelin, glucagone and GIP are measured within 180 minutes after the test meal.

Full Information

First Posted
August 28, 2014
Last Updated
September 20, 2019
Sponsor
Stoffwechselzentrum Rhein - Pfalz
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1. Study Identification

Unique Protocol Identification Number
NCT02235194
Brief Title
Effects of an Amino Acid and Chromium-picolinate Containing Drink on Glucose Metabolism
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 Type
Interventional

2. Study Status

Record Verification Date
September 2019
Overall Recruitment Status
Completed
Study Start Date
August 2014 (undefined)
Primary Completion Date
November 2015 (Actual)
Study Completion Date
November 2015 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Stoffwechselzentrum Rhein - Pfalz

4. Oversight

Data Monitoring Committee
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Type 2 Diabetes, Prediabetes

7. Study Design

Primary Purpose
Supportive Care
Study Phase
Not Applicable
Interventional Study Model
Crossover Assignment
Masking
ParticipantCare ProviderInvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
20 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Amino Acids, Chromium - Picolinate
Arm Type
Active Comparator
Arm Description
Verum drink containing the dietary supplements is taken with a test meal. INsulin and glucose response is documented for 180 minutes.
Arm Title
Placebo Drink
Arm Type
Placebo Comparator
Arm Description
Placebo Drink containing aroma only is taken with a test meal. INsulin and glucose response is documented for 180 minutes.
Intervention Type
Dietary Supplement
Intervention Name(s)
Amino Acid and chromium-picolinate containing drink
Intervention Description
Amino Acid and chromium - picolinate containg water ist taken with a test meal to study efects on glucose and insulin response.
Intervention Type
Dietary Supplement
Intervention Name(s)
Placebo Drink
Intervention Description
Placebo drink ist taken with a test meal to study efects on glucose and insulin response.
Primary Outcome Measure Information:
Title
Area under the curve for Glucose
Description
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').
Time Frame
0', 15', 30', 60', 90', 120', 150', 180' post test meal
Secondary Outcome Measure Information:
Title
AUC for insulin
Description
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').
Time Frame
0', 15', 30', 60', 90', 120', 150', 180' post test meal
Title
Markers of inflammation
Description
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)
Time Frame
at 0', 15', 30', 60', 90', 120', 150', 180' post test meal
Title
markers of lipid metabolism
Description
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'.
Time Frame
0', 15', 30', 60', 90', 120', 150', 180' post test meal
Title
Gut peptide hormones
Description
Area under the curve for GLP-1, ghrelin, glucagone and GIP are measured within 180 minutes after the test meal.
Time Frame
0', 15', 30', 60', 90', 120', 150', 180' post test meal

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
70 Years
Accepts Healthy Volunteers
No
Eligibility 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
Facility Information:
Facility Name
Stoffwechselzentrum Rhein Pfalz
City
Mannheim
ZIP/Postal Code
68163
Country
Germany

12. IPD Sharing Statement

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

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