# Diabetes Research and Training Center

> **NIH NIH P30** · UNIVERSITY OF CHICAGO · 2023 · $82,000

## Abstract

ABSTRACT
Hypothyroidism is a common endocrine disorder affecting nearly 10% of the US population. The first line
treatment of hypothyroidism is levothyroxine (L T4), a synthetic form of thyroid hormone. The primary goals of
treatment are to resolve hypothyroid symptoms and restore normal biochemical thyroid function. Managing
hypothyroidism is challenging because it often requires multiple L T4 dose adjustments over a patient's
lifetime. Cross-sectional studies of hypothyroidism management have demonstrated that at least one-third of
patients are over- or undertreated, which both lead to serious adverse health outcomes. Several outcome
studies have suggested that adverse cardiovascular events are more likely to occur the longer overtreatment
or undertreatment persist. While these studies have reinforced the importance of durable maintenance of
normal thyroid function levels, there are no established methods for clinicians or their patients to measure the
degree to which thyroid function is controlled over the treatment course. An intuitive measure of thyroid
function control is the serum value of thyroid stimulating hormone (TSH). However, TSH is a cross-sectional
marker of thyroid function and does not account for changes in thyroid function over time. Longitudinal TSH
trajectory represents a candidate outcome measure of thyroid function control during hypothyroidism
treatment. TSH trajectories have been previously studied to identify different classes of thyroid function
patterns during pregnancy, but not during thyroid hormone treatment. In addition, the time-in-range (TIR)
treatment parameter is a potential marker of thyroid function control over time. As an example, glycemic TIR, a
reported output of continuous glucose monitoring, measures the duration of time spent within specific glycemic
ranges and has emerged as a validated predictor of diabetes complications. Adapting a method used to
estimate therapeutic TIR from repeated measures of clotting parameters (i.e., INR) could allow for the
estimation of TIR of L T4 treatment from repeated TSH values. The primary goal of this NIDDK Diabetes
Research & Training Center (DRTC) Pilot & Feasibility application is to provide evidence for longitudinal
outcome measures of thyroid function control in the management of hypothyroidism. Using a large longitudinal
database of L T4-treated patients in the University of Chicago Medicine health system over 1 0 years (2010 -
2019), the Pl (Dr. Matthew Ettleson) will complete the following specific aims: 1) determine the relationship
between TSH trajectory class and cardiovascular outcomes (incidence of atrial fibrillation, heart failure, stroke,
and myocardial infarction), and 2) determine the association between a TSH-based therapeutic time-in-range
treatment parameter and cardiovascular outcomes. The findings of this study will serve as preliminary data for
a future research grant application investigating multiple approaches to improve hypothyroidism mana...

## Key facts

- **NIH application ID:** 10825331
- **Project number:** 3P30DK020595-46S1
- **Recipient organization:** UNIVERSITY OF CHICAGO
- **Principal Investigator:** GRAEME I BELL
- **Activity code:** P30 (R01, R21, SBIR, etc.)
- **Funding institute:** NIH
- **Fiscal year:** 2023
- **Award amount:** $82,000
- **Award type:** 3
- **Project period:** 1996-12-01 → 2028-03-31

## Primary source

NIH RePORTER: https://reporter.nih.gov/project-details/10825331

## Citation

> US National Institutes of Health, RePORTER application 10825331, Diabetes Research and Training Center (3P30DK020595-46S1). Retrieved via AI Analytics 2026-05-22 from https://api.ai-analytics.org/grant/nih/10825331. Licensed CC0.

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