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Metformin and Its Impact on the Substances Associated With NO Production in Prediabetes Patients.

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT03398356
Recruitment Status : Completed
First Posted : January 12, 2018
Results First Posted : August 24, 2020
Last Update Posted : August 24, 2020
Sponsor:
Information provided by (Responsible Party):
Edyta Sutkowska, Wroclaw Medical University

Brief Summary:

This study evaluates the effect of different doses of metformin on the function of endothelium in people with pre-diabetes. One group of the patients will receive metformin in dose: 1500 mg, the second one will receive 3000 mg/day.

The parameters from healthy volunteers will be taken only at the study beginning to compare the test results with the parameters from patients with pre-diabetes. This group will be not treated with metformin (no intervention)


Condition or disease Intervention/treatment Phase
PreDiabetes Impaired Fasting Glucose (IFG) Impaired Glucose Tolerance (IGT) Drug: Metformin Phase 4

Show Show detailed description

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 47 participants
Allocation: Randomized
Intervention Model: Crossover Assignment
Intervention Model Description:

The group of patients taking the drug at the target dose of 3 x 1000 after 4 weeks returned to the dose of 3 x 500 mg. The group of patients taking the drug at the target dose 3 x 500 mg consequently had this dose during the whole study period.

The basic parameters and biochemical parameters from healthy individuals at the beginning of the study were assessed to compare with patients with pre-diabetes. This group did not take the metformin and thus did not have further examination and lab-tests during the study.

Masking: Single (Investigator)
Masking Description: At the beginning of the study, patients are assigned a number by a nurse and are assigned to group A or B according to ID. When analyzing the results, the researchers only knows the numbers of blood samples.
Primary Purpose: Basic Science
Official Title: The Assessment of the Effect of Metformin and Its Serum Concentration on the Concentration of Substances Associated With the Production of Nitric Oxide in Patients With Impaired Carbohydrate Metabolism
Actual Study Start Date : October 20, 2017
Actual Primary Completion Date : December 30, 2018
Actual Study Completion Date : April 30, 2019

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Prediabetes

Arm Intervention/treatment
group A
metformin dose 3 x 500 mg
Drug: Metformin

for group A: 12 weeks metformin treatment in a final dose 3 x 500 mg

for group B: 3 weeks metformin treatment in a dose 3 x 500 mg, next: 3 weeks metformin treatment in a final dose 3 x 1000mg, next: 3 weeks metformin treatment in a dose 3 x 500 mg.

Other Names:
  • Metformax
  • Glucophage
  • Formetic
  • Siofor

group B
metformin dose 3 x 1000 mg
Drug: Metformin

for group A: 12 weeks metformin treatment in a final dose 3 x 500 mg

for group B: 3 weeks metformin treatment in a dose 3 x 500 mg, next: 3 weeks metformin treatment in a final dose 3 x 1000mg, next: 3 weeks metformin treatment in a dose 3 x 500 mg.

Other Names:
  • Metformax
  • Glucophage
  • Formetic
  • Siofor

No Intervention: group C
healthy volunteers who had basic parameters assessment and blood tests only at the beginning of the study



Primary Outcome Measures :
  1. Serum Levels of Metformin at Different Time Points [ Time Frame: 6 weeks from treatment start; 12 weeks from treatment start; 15 weeks from treatment start ]
    the serum concentration of the studied drug-metformin

  2. Serum Levels of Arginine at Different Time Points [ Time Frame: Baseline; 6 weeks from treatment start; 12 weeks from treatment start; 15 weeks from treatment start ]
    arginine serum concentration

  3. Serum Levels of ADMA at Different Time Points [ Time Frame: before study start; 6 weeks from treatment start; 12 weeks from treatment start; 15 weeks from treatment start ]
    ADMA- asymmetric dimethylarginine-serum concentration

  4. Serum Levels of SDMA at Different Time Points [ Time Frame: Baseline; 6 weeks from treatment start; 12 weeks from treatment start; 15 weeks from treatment start ]
    SDMA-symmetric dimethylarginine-serum concentration

  5. Serum Levels of Citrulline at Different Time Points [ Time Frame: Baseline; 6 weeks from treatment start; 12 weeks from treatment start; 15 weeks from treatment start ]
    serum concentration of the citrulline

  6. Serum Levels of DMA at Different Time Points [ Time Frame: Baseline; 6 weeks from treatment start; 12 weeks from treatment start; 15 weeks from treatment start ]
    DMA- dimethylamine, serum concentration



Information from the National Library of Medicine

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Ages Eligible for Study:   40 Years to 65 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion Criteria for treated groups ( A or B):

  • age: 40-65 years;
  • pre-diabetic status based on fasting plasma glucose (FPG) and / or OGTT;
  • without metformin before;
  • without ischemic heart disease in history;
  • without a stroke in a history;
  • without PAOD (peripheral arterial occlusive disease) in a history;
  • without active cancer in a history

Exclusion Criteria for treated groups (A or B):

  • age <40 or >65;
  • diabetes;
  • taking metformin before study;
  • active cancer;
  • history of macro-angiopathy (ischemic heart disease, stroke or TIA, PAOD);
  • serious gastrointestinal disease that may affect metformin tolerance;
  • renal failure with GFR<45 ml/min/1.73m2;
  • alanin transaminase > 3 x ULN

Inclusion criteria for healthy volunteers:

  • age: 40-65 years;
  • no carbo-hydrates disturbances (based on fasting plasma glucose (FPG) and/or OGTT);
  • without metformin before;
  • without ischemic heart disease in history;
  • without a stroke in a history;
  • without PAOD (peripheral arterial occlusive disease) in a history;
  • without active cancer in a history

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): NCT03398356


Locations
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Poland
NZOZ Nowy Dwór
Wroclaw, Lower Silesia, Poland, 54-438
Sponsors and Collaborators
Wroclaw Medical University
Investigators
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Principal Investigator: Edyta Sutkowska, PhD Wroclaw Medical University
  Study Documents (Full-Text)

Documents provided by Edyta Sutkowska, Wroclaw Medical University:
Publications of Results:

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Responsible Party: Edyta Sutkowska, MD, PhD; The Head of the Department and Division of Medical Rehabilitation, Wroclaw Medical University
ClinicalTrials.gov Identifier: NCT03398356    
Other Study ID Numbers: ST.C310.17.009
First Posted: January 12, 2018    Key Record Dates
Results First Posted: August 24, 2020
Last Update Posted: August 24, 2020
Last Verified: August 2020
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Yes
Plan Description: De-identified individual participant data for all primary outcome will be made available.
Supporting Materials: Study Protocol
Statistical Analysis Plan (SAP)
Time Frame: the results will be available after the publication of the study
Access Criteria: data will be available after giving permission by the Investigator

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Product Manufactured in and Exported from the U.S.: No
Keywords provided by Edyta Sutkowska, Wroclaw Medical University:
prediabetes
impaired fasting glucose
impaired glucose tolerance
metformin
nitric oxide
Additional relevant MeSH terms:
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Prediabetic State
Glucose Intolerance
Diabetes Mellitus
Glucose Metabolism Disorders
Metabolic Diseases
Endocrine System Diseases
Hyperglycemia
Metformin
Hypoglycemic Agents
Physiological Effects of Drugs