RECRUITING

Physiologic Markers of Cardiometabolic Risk in People With Type 1 Diabetes

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Study Overview

This clinical trial focuses on testing the efficacy of different digital interventions to promote re-engagement in cancer-related long-term follow-up care for adolescent and young adult (AYA) survivors of childhood cancer.

Description

More than 40% of young adults with type 1 diabetes (T1D) also have overweight or obesity. Each of these diagnoses increase the risk of adverse cardiovascular events. Investigators aim to obtain reference data for individuals with T1D who do not have overweight obesity, to understand how close GLP-1 analogue obesity treatment in those with overweight/obesity brings physiologic markers of cardiometabolic risk to those with BMI in the normal range. Specifically, investigators will describe how drivers of gluconeogenesis and lipemia (specifically measured as visceral fat ratio, insulin resistance, and postprandial lipemia,) that contribute to cardiometabolic risk in T1D change over time.

Official Title

Physiologic Markers of Cardiometabolic Risk in People With Type 1 Diabetes

Quick Facts

Study Start:2023-12-13

Study Completion:2028-06

Study Type:Not specified

Phase:Not Applicable

Enrollment:Not specified

Status:RECRUITING

Study ID

NCT06105931

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Ages Eligible for Study:18 Years to 30 Years

Sexes Eligible for Study:ALL

Accepts Healthy Volunteers:No

Standard Ages:ADULT

Inclusion Criteria	Exclusion Criteria
* Provision of signed and dated informed consent form * Stated willingness to comply with all study procedures and availability for the duration of the study * Male or female, aged 18 to ≤30 years * Diagnosed T1D for at least 12 months and with BMI \<25 kg/m2. * HbA1c ≤10% * Clinical use of continuous glucose monitoring (CGM) * Any known laboratory safety parameter consistently outside the below extended laboratory ranges in the past year: 1. Baseline creatinine \>1.0mg 2. Hypertriglyceridemia (\>400 mg/dl) 3. ALT ≥3.5 times the upper normal limit (UNL)	* Current use of adjunctive diabetes medication or anti-obesity medication * Insulin dose \<0.5 units/kg/day * Use of lipid lowering prescription medication other than statins or omega-3 products * Doesn't meet MRI safety criteria or having claustrophobia * Known liver disease other than non-alcoholic steatosis or non-alcoholic fatty liver disease * Known renal impairment * Pregnancy or lactation, or planning to become pregnant during the study period. * Anemia or known hematologic condition impacting HbA1c reading, or another medical condition that precludes participation. * Treatment with another investigational drug within the past 1 month * Past medical history of or self-reported corn allergy

Inclusion Criteria

Exclusion Criteria

* Provision of signed and dated informed consent form
* Stated willingness to comply with all study procedures and availability for the duration of the study
* Male or female, aged 18 to ≤30 years
* Diagnosed T1D for at least 12 months and with BMI \<25 kg/m2.
* HbA1c ≤10%
* Clinical use of continuous glucose monitoring (CGM)
* Any known laboratory safety parameter consistently outside the below extended laboratory ranges in the past year:
1. Baseline creatinine \>1.0mg
2. Hypertriglyceridemia (\>400 mg/dl)
3. ALT ≥3.5 times the upper normal limit (UNL)

* Current use of adjunctive diabetes medication or anti-obesity medication
* Insulin dose \<0.5 units/kg/day
* Use of lipid lowering prescription medication other than statins or omega-3 products
* Doesn't meet MRI safety criteria or having claustrophobia
* Known liver disease other than non-alcoholic steatosis or non-alcoholic fatty liver disease
* Known renal impairment
* Pregnancy or lactation, or planning to become pregnant during the study period.
* Anemia or known hematologic condition impacting HbA1c reading, or another medical condition that precludes participation.
* Treatment with another investigational drug within the past 1 month
* Past medical history of or self-reported corn allergy

Contacts and Locations

Study Contact

Rehema Mtawali

CONTACT

(475) 414-4035

rehema.mtawali@yale.edu

Principal Investigator

Michelle Van Name, MD

PRINCIPAL_INVESTIGATOR

Yale University

Study Locations (Sites)

Yale Pediatric Diabetes Research

New Haven, Connecticut, 06520

United States

Collaborators and Investigators

Sponsor: Yale University

Michelle Van Name, MD, PRINCIPAL_INVESTIGATOR, Yale University

Study Record Dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Registration Dates

Study Start Date2023-12-13

Study Completion Date2028-06

Study Record Updates

Study Start Date2023-12-13

Study Completion Date2028-06

Terms related to this study

Additional Relevant MeSH Terms

type1diabetes
Obesity