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Impact of Metformin on Immunity

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: NCT03713801
Recruitment Status : Active, not recruiting
First Posted : October 22, 2018
Last Update Posted : February 8, 2022
Sponsor:
Information provided by (Responsible Party):
The University of Texas Health Science Center at San Antonio

Tracking Information
First Submitted Date  ICMJE October 17, 2018
First Posted Date  ICMJE October 22, 2018
Last Update Posted Date February 8, 2022
Actual Study Start Date  ICMJE January 14, 2019
Actual Primary Completion Date July 4, 2020   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: October 19, 2018)
Change in antibody responses to PCV13 [ Time Frame: Change from 4 weeks to 8 weeks ]
The primary outcome will be antibody responses to PCV13. Antibody levels of each of the 13 different serotypes (1, 3, 4, 5, 6A, 6B, 7F, 9V, 14, 18C, 19A, 19F and 23F) will be compared between the pre-treatment values and the post treatment values.
Original Primary Outcome Measures  ICMJE Same as current
Change History
Current Secondary Outcome Measures  ICMJE
 (submitted: October 19, 2018)
Measure of immunophenotypes [ Time Frame: Baseline, 4 weeks and 8 weeks ]
The distribution of immunophenotypes will be presented descriptively at each time point for each treatment group. To determine which immunophenotypes differed between MET and placebo groups, changes will be determined using within-patient cell count ratios for each measured phenotype between baseline and 6-weeks of study drug treatment and between baseline and the 30 days after PCV13.
Original Secondary Outcome Measures  ICMJE Same as current
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Impact of Metformin on Immunity
Official Title  ICMJE Metformin and Vaccine Response in Older Adults
Brief Summary To determine whether metformin (MET) can improve the immune response to the pneumococcal conjugate vaccine (PCV-13) in older adults.
Detailed Description

The objective of this study is to determine whether metformin (MET) can improve the immune response to the pneumococcal conjugate vaccine (PCV-13) in older adults, and if this effect is mediated by the gut microbiota.

The proposed research projects will provide the necessary pilot data for future, more definitive, studies that will evaluate the impact of immunomodulatory therapies, such as MET therapy, on the aging immune system. The specific aims are:

Aim 1. Compare PCV13 vaccine response in elderly adults (≥63 years of age) treated with MET vs. placebo. For this study, 50 elderly volunteers will be enrolled and randomly assigned to receive MET or placebo. The hypothesis that MET can improve vaccine responsiveness by measuring serotype-specific IgG concentrations before and 30 days after PCV13 administration will be tested.

Aim 2. Determine whether the frequencies of immunophenotypes differ between elderly adults treated with MET vs. placebo. The mechanisms of MET's effect on the immune system by comparing immunophenotypes of MET and placebo groups between baseline and prior to PCV13 and between baseline and 30 days after PCV13 administration will be explored.

Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 1
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Triple (Participant, Care Provider, Investigator)
Primary Purpose: Basic Science
Condition  ICMJE
  • Aging
  • Vaccine Response Impaired
Intervention  ICMJE
  • Drug: Metformin
    Total daily dose titrated up to 1500 mg po q day over the course of 3 weeks and continued for a total exposure of 12 weeks.
    Other Name: Glucophage
  • Drug: Placebo
    Placebo tablets titrated up to 3 tablets over the course of 3 weeks and then continued as 3 daily for a total exposure of 12 weeks
    Other Name: Placebo oral tablet
Study Arms  ICMJE
  • Experimental: Metformin
    Dosage is increased over the first 3 weeks up to three 500 mg tablets a day at 3 weeks, then continued on 3 tablets daily for a further 9 weeks.
    Intervention: Drug: Metformin
  • Placebo Comparator: Placebo
    Placebo tablet dosage is increased over the first 3 weeks up to three tablets a day at 3 weeks, then continued on 3 tablets daily for a further 9 weeks.
    Intervention: Drug: Placebo
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Active, not recruiting
Actual Enrollment  ICMJE
 (submitted: February 5, 2021)
18
Original Estimated Enrollment  ICMJE
 (submitted: October 19, 2018)
50
Estimated Study Completion Date  ICMJE December 31, 2022
Actual Primary Completion Date July 4, 2020   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

Inclusion Criteria:

  1. Age 63 to 89 years of age
  2. No history of pneumococcal vaccinations
  3. Able to take oral medications
  4. Able to provide informed consent
  5. Not currently taking metformin

Exclusion Criteria:

  1. Previous vaccination with any pneumococcal vaccine
  2. Metformin within the last 6 months
  3. Contraindication for PCV13
  4. History of severe adverse reaction associated with any vaccine component
  5. Residence in long-term care facility
  6. Diagnosis of diabetes (diagnosis of pre-diabetes okay)
  7. Chronic renal disease (or eGFR <50 mL/min) or renal failure (defined as receipt of renal dialysis or transplant) or nephrotic syndrome
  8. History of adverse reaction or contraindications associated with metformin
  9. Recent history or plan for radiocontrast
  10. Self-reported dementia or severe cognitive impairment
  11. Receipt of blood products within 6 months before enrollment
  12. History of heart disease (New York Heart Classification greater than class II; more than non-specific ST-T wave changes on the ECG)
  13. History of chronic obstructive pulmonary disease
  14. Poorly controlled blood pressure (systolic BP>160, diastolic BP>90 mmHg)
  15. History of an immunodeficiency
  16. Use of use of investigational products, antibiotics, probiotics, or systemic immunosuppressive therapy (systemic steroids) within 1 month of study start; patients who are taking these medications chronically, with no expected discontinuation during the study period would not be considered ineligible.
  17. Treatment with anticoagulants (warfarin)
  18. Donated blood within the last 2 months
  19. Subject is considered unsuitable for the study in the opinion of the investigator for any other reason
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 63 Years to 90 Years   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE Yes
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE United States
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT03713801
Other Study ID Numbers  ICMJE 20180171H
Has Data Monitoring Committee Yes
U.S. FDA-regulated Product
Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No
IPD Sharing Statement  ICMJE
Plan to Share IPD: No
Current Responsible Party The University of Texas Health Science Center at San Antonio
Original Responsible Party Same as current
Current Study Sponsor  ICMJE The University of Texas Health Science Center at San Antonio
Original Study Sponsor  ICMJE Same as current
Collaborators  ICMJE Not Provided
Investigators  ICMJE
Principal Investigator: Grace Lee, PhD UT Health San Antonio
PRS Account The University of Texas Health Science Center at San Antonio
Verification Date February 2022

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP