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Impact of Metformin on Immunity

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ClinicalTrials.gov Identifier: NCT03713801
Recruitment Status : Recruiting
First Posted : October 22, 2018
Last Update Posted : November 20, 2018
Sponsor:
Information provided by (Responsible Party):
The University of Texas Health Science Center at San Antonio

Brief Summary:
To determine whether metformin (MET) can improve the immune response to the pneumococcal conjugate vaccine (PCV-13) in older adults.

Condition or disease Intervention/treatment Phase
Aging Vaccine Response Impaired Drug: Metformin Drug: Placebo Phase 1

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 : Interventional  (Clinical Trial)
Estimated Enrollment : 50 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Triple (Participant, Care Provider, Investigator)
Primary Purpose: Basic Science
Official Title: Metformin and Vaccine Response in Older Adults
Estimated Study Start Date : January 31, 2019
Estimated Primary Completion Date : December 31, 2019
Estimated Study Completion Date : December 31, 2019

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
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.
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

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.
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




Primary Outcome Measures :
  1. 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.


Secondary Outcome Measures :
  1. 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.



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Ages Eligible for Study:   63 Years to 90 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Criteria

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.

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): NCT03713801


Contacts
Contact: Grace Lee, PhD 12104508097 leeg3@uthscsa.edu

Locations
United States, Texas
UT Health San Antonio Recruiting
San Antonio, Texas, United States, 78229
Contact: Grace Lee, PhD    210-450-8097    leeg3@uthscsa.edu   
Sponsors and Collaborators
The University of Texas Health Science Center at San Antonio
Investigators
Principal Investigator: Grace Lee, PhD UT Health San Antonio

Responsible Party: The University of Texas Health Science Center at San Antonio
ClinicalTrials.gov Identifier: NCT03713801     History of Changes
Other Study ID Numbers: 20180171H
First Posted: October 22, 2018    Key Record Dates
Last Update Posted: November 20, 2018
Last Verified: October 2018
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No

Additional relevant MeSH terms:
Metformin
Hypoglycemic Agents
Physiological Effects of Drugs