- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT04101045
Pathogenesis of the Cardiometabolic Risk in Youth With Type 1 Diabetes
February 8, 2023 updated by: Yale University
The purpose of this study is to quantitate hepatic de novo lipogenesis (DNL) in youth with poorly-controlled type 1 diabetes (T1D) (HbA1c >8.5%), youth with T1D who achieve targeted glycemic control (HbA1c <7.5%) and lean controls.
Hypothesis: Youth with poor glycemic control experience higher fractional hepatic DNL during the fasting and the postprandial states than youth who achieve targeted glycemic control and lean controls.
Study Overview
Status
Terminated
Conditions
Intervention / Treatment
Detailed Description
What is not known, is whether hepatic de novo lipogenesis (DNL) contributes to dyslipidemia in this in patients with type 1 diabetes (T1D).
The aim of the study is to test the hypothesis that an enhanced rate of DNL largely contributes to dyslipidemia occurring in youth with poorly-controlled T1D.
According to this hypothesis, youth with poorly-regulated T1D experience a state of persistent insulin independent, highly variable fluctuations of glucose, and other sugars, through the glycolytic pathway that result in an enhancement of hepatic DNL and an increased production of triglycerides (TG).
Newly-formed TG are packaged into large-VLDL that are secreted into the circulation contributing to an increase in plasma TG.
When the TG concentration in the hepatocytes exceeds the ability of the liver to secrete TG, the latter start accumulating leading to hepatic steatosis.
Study Type
Interventional
Enrollment (Actual)
7
Phase
- Not Applicable
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
-
-
Connecticut
-
New Haven, Connecticut, United States, 06511
- Yale University School of Medicine
-
-
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.
Eligibility Criteria
Ages Eligible for Study
13 years to 22 years (ADULT, CHILD)
Accepts Healthy Volunteers
Yes
Genders Eligible for Study
All
Description
Inclusion Criteria:
- HbA1c >8.5% for the group with poorly controlled diabetes
- HbA1c <7.5% for the well-controlled patients
- T1D for at least 12 months (T1D groups only)
- Negative pregnancy test (all groups)
Exclusion Criteria:
- Baseline creatinine >1
- Being on medications affecting glucose concentrations other than insulin
- Positive pregnancy test
- Endocrinopathies
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: BASIC_SCIENCE
- Allocation: NON_RANDOMIZED
- Interventional Model: PARALLEL
- Masking: NONE
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
ACTIVE_COMPARATOR: Poorly-controlled T1D
Patients in this group will have poorly-controlled T1D (HbA1c >8.5%).
|
Each participant consumes a dinner scaled to his/her energy needs which is prepared by the metabolic kitchen.
Dinner will be provided beforehand if patient does this portion at home.
The participant consumes the first of three doses of D2O.
Two additional doses of D20 are given at on day 1 and on day 2. The total D2O given (3 ml per kg of body water) is designed to raise body deuterium levels to 0.3% and is administered as described above to maintain steady state until the end of the study.
At the HRU, an IV catheter will be inserted in order to collect blood to assess DNL.
Blood draws begin during the fasting state to assess basal rates of DNL and then for six hours after the consumption of a glucose/fructose beverage (75g glucose and 25g fructose ) to assess postprandial rates of DNL.
Blood draws will be taken 15 minutes before ingestion of the sugar beverage, then for every half hour for 6 hours.
|
ACTIVE_COMPARATOR: Controlled T1D
Patients in this group will have T1D and achieve targeted glycemic control (HbA1c <7.5%).
|
Each participant consumes a dinner scaled to his/her energy needs which is prepared by the metabolic kitchen.
Dinner will be provided beforehand if patient does this portion at home.
The participant consumes the first of three doses of D2O.
Two additional doses of D20 are given at on day 1 and on day 2. The total D2O given (3 ml per kg of body water) is designed to raise body deuterium levels to 0.3% and is administered as described above to maintain steady state until the end of the study.
At the HRU, an IV catheter will be inserted in order to collect blood to assess DNL.
Blood draws begin during the fasting state to assess basal rates of DNL and then for six hours after the consumption of a glucose/fructose beverage (75g glucose and 25g fructose ) to assess postprandial rates of DNL.
Blood draws will be taken 15 minutes before ingestion of the sugar beverage, then for every half hour for 6 hours.
|
ACTIVE_COMPARATOR: Lean controls
Patients in this group will not have T1D.
|
Each participant consumes a dinner scaled to his/her energy needs which is prepared by the metabolic kitchen.
Dinner will be provided beforehand if patient does this portion at home.
The participant consumes the first of three doses of D2O.
Two additional doses of D20 are given at on day 1 and on day 2. The total D2O given (3 ml per kg of body water) is designed to raise body deuterium levels to 0.3% and is administered as described above to maintain steady state until the end of the study.
At the HRU, an IV catheter will be inserted in order to collect blood to assess DNL.
Blood draws begin during the fasting state to assess basal rates of DNL and then for six hours after the consumption of a glucose/fructose beverage (75g glucose and 25g fructose ) to assess postprandial rates of DNL.
Blood draws will be taken 15 minutes before ingestion of the sugar beverage, then for every half hour for 6 hours.
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Fractional hepatic DNL
Time Frame: Baseline to Six hours
|
% Fractional hepatic DNL
|
Baseline to Six hours
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Collaborators
Investigators
- Principal Investigator: Nicola Santoro, MD, PhD, Assistant Professor of Pediatrics (Endocrinology)
Publications and helpful links
The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.
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 Major Dates
Study Start (ACTUAL)
November 21, 2019
Primary Completion (ACTUAL)
March 30, 2022
Study Completion (ACTUAL)
March 30, 2022
Study Registration Dates
First Submitted
September 17, 2019
First Submitted That Met QC Criteria
September 19, 2019
First Posted (ACTUAL)
September 24, 2019
Study Record Updates
Last Update Posted (ACTUAL)
February 13, 2023
Last Update Submitted That Met QC Criteria
February 8, 2023
Last Verified
February 1, 2023
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- 2000025170
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
NO
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
No
Studies a U.S. FDA-regulated device product
No
product manufactured in and exported from the U.S.
Yes
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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