Co-administration of Thiamine Pyrophosphate and Metformin in Type 2 Diabetes
Status:
Not yet recruiting
Trial end date:
2022-03-01
Target enrollment:
Participant gender:
Summary
Chronic non-infectious diseases have a bigger impact and a higher prevalence every day
world-wide. Among them, diabetes stands out being the number one cause of death from
degenerative chronic illness in Mexico. Diabetes not only affects quality of life, it can
also lead to severe complications that have a great economic impact as well as a health
impact on the patient and their family. Some of the complications include liver failure and
hypertension. This whole problem can be dated back to an initial hyperglycemic state that
when left untreated further develops into insulin resistance, chronic inflammation, metabolic
syndrome and diabetes. The purpose of this study is to stop this chain reaction that starts
with every hyperglycemic patient by adding thiamine pyrophosphate to the treatment plan of
patients diagnosed with type 2 diabetes that are poorly managed with metformin monotherapy.
Thiamine pyrophosphate is a form of B1 vitamin that plays an important role as a coenzyme in
multiple metabolic routes including the link between glycolysis and Krebs cycle, fatty acids
metabolism and branched-chain amino acid metabolism. By doing so, these pathways improve
their function and efficiency and thereby utilize plasma glucose. This in turn, decreases the
formation of advanced glycation end products (AGEs) which prevents the formation of reactive
oxygen and nitrogen species, ultimately there is also an anti-oxidative mechanism involved
that improves the inflammatory state the patient is living with. Our hypothesis is that by
adding thiamine pyrophosphate to the treatment of patients taking metformin, there will be
important progress regarding the inflammatory and metabolic control of patients with type 2
diabetes.
The study will have a duration of approximately 4 months after the total sample is recruited.
During this time, subjects will first be examined to determine their eligibility according to
the pre-established criteria, in case of inclusion in the study they will sign an informed
consent after reading it thoroughly and having answered all their questions. Baseline labs
will be taken for every subject for future comparison. They will then be randomized into two
parallel groups: an experimental group that will receive weekly infusions of saline infused
with 1 gram of thiamine pyrophosphate or a placebo group that will also receive weekly
infusions of pure saline. The patients as well as the doctors treating them will be blinded
to the assignment of either group. This model will be carried out for a duration of 12 weeks
total, during which every patient will continue their metformin treatment with their
tolerated dose. There will be verification of treatment adherence by counting the metformin
pills during every weekly visit. For the assessment of dependent variables there will be a
visit every month with a blinded doctor. These visits will be for: physical and clinical
evaluation, evaluation of adverse events, evaluation of treatment adherence and a heart rate
variability study. The first and third months a questionnaire about lifestyle will be added
to the visit schedule. On the third month, final lab tests will be performed. Finally, one
month after completing the treatment, a final visit will be scheduled for a clinical and
physical evaluation to make sure there are no problems.