The COVID-19 and Diabetes Assessment (CODA) Study

Study Updated 03/28/2024

Study Design: Prospective Observational
PCORnet Infrastructure: Collaboration, CDM (+supplemental data), Engagement, Single IRB
Principal Investigator: Russell Rothman
Site Name: Vanderbilt University Medical Center (VUMC)
PCORnet® Network Partner: STAR
Funder: NIDDK/NIH
Funding Date: 2023
Study Duration: 2023 – 2027
Participating Clinical Research Networks: GPC, INSIGHT, OneFlorida+, PaTH, PEDSnet, REACHnet, STAR
Therapeutic Area: Metabolic Disorders
Condition: COVID-19, Diabetes
Population: 18 Years and older (Adult, Older Adult)
Status: Not yet recruiting

Research Question(s):  The study will answer important questions patients are asking about the link between diabetes and COVID-19.

  1. To what extent does COVID-19 cause worse glycemic control, vascular function, inflammation, and increased risk for blood clots in people with either type 1 or type 2 diabetes?
  2. The study will also explore the role of genomic, social, and environmental factors on metabolic function and the impact of COVID-19 infection and COVID-19 treatments on diabetes-related outcomes.

Understanding How Antibiotic Use Affects Childhood Obesity and Growth

Study Updated 03/05/2024

ClinicalTrials.gov#: NCT02744846

Study Design: Retrospective Observational
PCORnet Infrastructure: Collaboration, CDM, Engagement
Principal Investigator: Jason Block
Site Name: Harvard Pilgrim Healthcare Institute
PCORnet® Network Partner: Legacy PCORnet Partner
Funder: Patient-Centered Outcomes Research Institute (PCORI); (Project webpage)
Funding Date: 2015
Study Duration: 2015 – 2018
Participating Clinical Research Networks: ADVANCE, GPC, INSIGHT, OneFlorida+, PEDSnet, REACHnet, STAR
Therapeutic Area: Metabolic Disorders
Population: up to 11 Years (Child)
Status: Completed

Research Question(s):
How does antibiotic use before age two affect weight and growth in children?

Primary Publication(s):
Early Antibiotic Exposure and Weight Outcomes in Young Children
Block JP, Bailey LC, Gillman M, et al. Early Antibiotic Exposure and Weight Outcomes in Young Children. Pediatrics, 2018; 142(6), p.e20180290.

Maternal antibiotic use during pregnancy and childhood obesity at age 5 years
Heerman WJ, Daley MF, Boone-Heinonen J, et al. Maternal antibiotic use during pregnancy and childhood obesity at age 5 years. Int J Obes (Lond). 2019;43(6):1202-1209. DOI: 10.1038/s41366-018-0316-6.

A Patient-Centered PaTH to Addressing Diabetes

Study Updated 03/05/2024

Study Website: The PaTH to Health: Diabetes Study
ClinicalTrials.gov#: NCT02788903
Study Design: Retrospective Observational
PCORnet Infrastructure: Collaboration, CDM (+supplemental data), Engagement
Principal Investigator: Jennifer Kraschnewski
Site Name: Pennsylvania State University
PCORnet® Network Partner: PaTH
Funder: Patient-Centered Outcomes Research Institute (PCORI)
Funding Date: 2016
Study Duration: 2016 – 2021
Participating Clinical Research Networks: GPC, PaTH
Therapeutic Area: Metabolic Disorders
Condition: COVID-19; Diabetes; Obesity
Population: 18 Years and older (Adult, Older Adult)
Status: Completed

Research Question(s):

  1. How often is intensive behavioral therapy (IBT) being utilized in primary care and how has it impacted weight and diabetes outcomes for patients with and at-risk of type 2 diabetes?
  2. What is the impact of telemedicine utilization during the COVID-19 pandemic for patients with and at-risk of type 2 diabetes?
  3. What are demographic and clinical characteristics associated with severe COVID-19 outcomes across multiple phases of the COVID pandemic for patients with or at-risk of type 2 diabetes?

Primary Publication(s):
A Patient-Centered PaTH to Address Diabetes: Protocol for a Study on the Impact of Obesity Counseling
Kraschnewski JL, Kong L, Francis E, Yeh HC, Bryce C, Poger J, Lehman E. A Patient-Centered PaTH to Address Diabetes: Protocol for a Study on the Impact of Obesity Counseling. JMIR Res Protoc. 2019 Apr 4;8(4):e12054. doi: 10.2196/12054. PubMed PMID: 30946024

Medications and Weight Gain in PCORnet: The MedWeight Study

Study Updated 03/28/2024

Study Website: Medications and Weight Gain in PCORnet: The MedWeight Study
Study Design: Prospective Observational
PCORnet Infrastructure: Collaboration, CDM, Engagement, Single IRB
Principal Investigator: Jason Block
Site Name: Harvard Pilgrim Healthcare Institute
PCORnet® Network Partner: Legacy PCORnet Partner
Funder: NIH
Funding Date: 2020
Study Duration: 2020 – 2024
Participating Clinical Research Networks: GPC, OneFlorida+, PEDSnet, STAR
Therapeutic Area: Metabolic Disorders
Condition: Obesity; Diabetes
Population: Children 5 to 19 Years and Adults 20+ Years (Child, Adult)
Status: Completed

Research Question(s):
How do six classes of commonly prescribed medications influence weight, risk for diabetes, and cholesterol over time?