NCT04101045

Brief Summary

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.

Trial Health

57
Monitor

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
7

participants targeted

Target at below P25 for not_applicable

Timeline
Completed

Started Nov 2019

Typical duration for not_applicable

Geographic Reach
1 country

1 active site

Status
terminated

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

September 17, 2019

Completed
7 days until next milestone

First Posted

Study publicly available on registry

September 24, 2019

Completed
2 months until next milestone

Study Start

First participant enrolled

November 21, 2019

Completed
2.4 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

March 30, 2022

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

March 30, 2022

Completed
Last Updated

February 13, 2023

Status Verified

February 1, 2023

Enrollment Period

2.4 years

First QC Date

September 17, 2019

Last Update Submit

February 8, 2023

Conditions

Type 1 DiabetesDe Novo Lipogenesis

Outcome Measures

Primary Outcomes (1)

  • Fractional hepatic DNL

    % Fractional hepatic DNL

    Baseline to Six hours

Study Arms (3)

Poorly-controlled T1D

ACTIVE COMPARATOR

Patients in this group will have poorly-controlled T1D (HbA1c \>8.5%).

Diagnostic Test: Oral Glucose Tolerance Test

Controlled T1D

ACTIVE COMPARATOR

Patients in this group will have T1D and achieve targeted glycemic control (HbA1c \<7.5%).

Diagnostic Test: Oral Glucose Tolerance Test

Lean controls

ACTIVE COMPARATOR

Patients in this group will not have T1D.

Diagnostic Test: Oral Glucose Tolerance Test

Interventions

Oral Glucose Tolerance TestDIAGNOSTIC_TEST

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.

Controlled T1DLean controlsPoorly-controlled T1D

Eligibility Criteria

Age13 Years - 22 Years
Sexall
Healthy VolunteersYes
Age GroupsChild (0-17), Adult (18-64)

You may qualify if:

  • 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)

You may not qualify if:

  • Baseline creatinine \>1
  • Being on medications affecting glucose concentrations other than insulin
  • Positive pregnancy test
  • Endocrinopathies

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Yale University School of Medicine

New Haven, Connecticut, 06511, United States

Location

Related Publications (1)

  • Monga Kravetz A, Testerman T, Galuppo B, Graf J, Pierpont B, Siebel S, Feinn R, Santoro N. Effect of Gut Microbiota and PNPLA3 rs738409 Variant on Nonalcoholic Fatty Liver Disease (NAFLD) in Obese Youth. J Clin Endocrinol Metab. 2020 Oct 1;105(10):e3575-85. doi: 10.1210/clinem/dgaa382.

    PMID: 32561908DERIVED

MeSH Terms

Conditions

Diabetes Mellitus, Type 1

Interventions

Glucose Tolerance Test

Condition Hierarchy (Ancestors)

Diabetes MellitusGlucose Metabolism DisordersMetabolic DiseasesNutritional and Metabolic DiseasesEndocrine System DiseasesAutoimmune DiseasesImmune System Diseases

Intervention Hierarchy (Ancestors)

Blood Chemical AnalysisClinical Chemistry TestsClinical Laboratory TechniquesDiagnostic Techniques and ProceduresDiagnosisDiagnostic Techniques, EndocrineInvestigative Techniques

Study Officials

  • Nicola Santoro, MD, PhD

    Assistant Professor of Pediatrics (Endocrinology)

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NON RANDOMIZED
Masking
NONE
Purpose
BASIC SCIENCE
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

September 17, 2019

First Posted

September 24, 2019

Study Start

November 21, 2019

Primary Completion

March 30, 2022

Study Completion

March 30, 2022

Last Updated

February 13, 2023

Record last verified: 2023-02

Data Sharing

IPD Sharing
Will not share

Locations

US(1)