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

NCT ID: NCT02235194

Last Updated: 2019-09-24

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

20 participants

Study Classification

INTERVENTIONAL

Study Start Date

2014-08-31

Study Completion Date

2015-11-30

Brief Summary

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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.

Detailed Description

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Conditions

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Type 2 Diabetes Prediabetes

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

CROSSOVER

Primary Study Purpose

SUPPORTIVE_CARE

Blinding Strategy

QUADRUPLE

Participants Caregivers Investigators Outcome Assessors

Study Groups

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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.

Group Type ACTIVE_COMPARATOR

Amino Acid and chromium-picolinate containing drink

Intervention Type 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

Intervention Type DIETARY_SUPPLEMENT

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

Placebo Drink

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

Group Type PLACEBO_COMPARATOR

Amino Acid and chromium-picolinate containing drink

Intervention Type 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

Intervention Type DIETARY_SUPPLEMENT

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

Interventions

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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.

Intervention Type DIETARY_SUPPLEMENT

Placebo Drink

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

Intervention Type DIETARY_SUPPLEMENT

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Maximum Eligible Age

70 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Stoffwechselzentrum Rhein - Pfalz

OTHER

Sponsor Role lead

Responsible Party

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Dr. Per Humpert

Privatdozent Dr. Per M. Humpert

Responsibility Role PRINCIPAL_INVESTIGATOR

Locations

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Stoffwechselzentrum Rhein Pfalz

Mannheim, , Germany

Site Status

Countries

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Germany

Other Identifiers

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SWZRP-14-01

Identifier Type: -

Identifier Source: org_study_id

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