NCT02235194

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
20

participants targeted

Target at below P25 for not_applicable type-2-diabetes

Timeline
Completed

Started Aug 2014

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

August 1, 2014

Completed
27 days until next milestone

First Submitted

Initial submission to the registry

August 28, 2014

Completed
12 days until next milestone

First Posted

Study publicly available on registry

September 9, 2014

Completed
1.1 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

November 1, 2015

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

November 1, 2015

Completed
Last Updated

September 24, 2019

Status Verified

September 1, 2019

Enrollment Period

1.3 years

First QC Date

August 28, 2014

Last Update Submit

September 20, 2019

Conditions

Type 2 DiabetesPrediabetes

Outcome Measures

Primary Outcomes (1)

  • 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').

    0', 15', 30', 60', 90', 120', 150', 180' post test meal

Secondary Outcomes (4)

  • AUC for insulin

    0', 15', 30', 60', 90', 120', 150', 180' post test meal

  • Markers of inflammation

    at 0', 15', 30', 60', 90', 120', 150', 180' post test meal

  • markers of lipid metabolism

    0', 15', 30', 60', 90', 120', 150', 180' post test meal

  • Gut peptide hormones

    0', 15', 30', 60', 90', 120', 150', 180' post test meal

Study Arms (2)

Amino Acids, Chromium - Picolinate

ACTIVE COMPARATOR

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 drinkDietary Supplement: Placebo Drink

Placebo Drink

PLACEBO COMPARATOR

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 drinkDietary Supplement: Placebo Drink

Interventions

Amino Acid and chromium-picolinate containing drinkDIETARY_SUPPLEMENT

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

Amino Acids, Chromium - PicolinatePlacebo Drink
Placebo DrinkDIETARY_SUPPLEMENT

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

Amino Acids, Chromium - PicolinatePlacebo Drink

Eligibility Criteria

Age18 Years - 70 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Stoffwechselzentrum Rhein Pfalz

Mannheim, 68163, Germany

Location

MeSH Terms

Conditions

Diabetes Mellitus, Type 2Prediabetic State

Interventions

Amino Acids

Condition Hierarchy (Ancestors)

Diabetes MellitusGlucose Metabolism DisordersMetabolic DiseasesNutritional and Metabolic DiseasesEndocrine System Diseases

Intervention Hierarchy (Ancestors)

Amino Acids, Peptides, and Proteins

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
QUADRUPLE
Who Masked
PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
Purpose
SUPPORTIVE CARE
Intervention Model
CROSSOVER
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Privatdozent Dr. Per M. Humpert

Study Record Dates

First Submitted

August 28, 2014

First Posted

September 9, 2014

Study Start

August 1, 2014

Primary Completion

November 1, 2015

Study Completion

November 1, 2015

Last Updated

September 24, 2019

Record last verified: 2019-09

Locations

DE(1)