NCT02697201

Brief Summary

Insulin promotes the clearance of sugars from the blood into skeletal muscle and fat cells for use as energy; it also promotes storage of excess nutrients as fat. Type 2 diabetes occurs when the cells of the body become resistant to the effects of insulin, and this causes high blood sugar and contributes to a build-up of fat in muscle, pancreas, liver, and the heart. Understanding how insulin resistance occurs will pave the way for new therapies aimed at preventing and treating type 2 diabetes. Mitochondria are cellular structures that are responsible for turning nutrients from food, into the energy that our cells run on. As a result, mitochondria are known as "the powerhouse of the cell." Mitochondria are dynamic organelles that can move within a cell to the areas where they are needed, and can fuse together to form large, string-like, tubular networks or divide into small spherical structures. The name of this process is "mitochondrial dynamics" and the process keeps the cells healthy. However, when more food is consumed compared to the amount of energy burned, mitochondria may become overloaded and dysfunctional resulting in a leak of partially metabolized nutrients that can interfere with the ability of insulin to communicate within the cell. This may be a way for the cells to prevent further uptake of nutrients until the current supply has been exhausted. However, long term overload of the mitochondria may cause blood sugar levels to rise and lead to the development of type 2 diabetes. This study will provide information about the relationship between mitochondrial dynamics, insulin resistance and type 2 diabetes.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
25

participants targeted

Target at P25-P50 for early_phase_1

Timeline
Completed

Started Jul 2016

Longer than P75 for early_phase_1

Geographic Reach
1 country

1 active site

Status
completed

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

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

February 18, 2016

Completed
14 days until next milestone

First Posted

Study publicly available on registry

March 3, 2016

Completed
4 months until next milestone

Study Start

First participant enrolled

July 1, 2016

Completed
4.8 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

May 1, 2021

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

May 1, 2021

Completed
Last Updated

July 27, 2021

Status Verified

July 1, 2021

Enrollment Period

4.8 years

First QC Date

February 18, 2016

Last Update Submit

July 23, 2021

Conditions

Insulin Resistance

Keywords

Mitochondrial DynamicsInsulin Resistance

Outcome Measures

Primary Outcomes (1)

  • Effects of lipid infusion on mitochondrial fission

    Fission will be assessed from quantitative measures of dynamin-related protein-1. The unit of assessment is arbitrary units of blot intensity and is expressed as AU.

    5 years

Secondary Outcomes (2)

  • Effects of lipid infusion on mitochondrial function

    5 years

  • Insulin sensitivity

    5 years

Study Arms (2)

Intralipid Infusion, then Saline

EXPERIMENTAL

Participants in this arm will first receive a lipid infusion. Then 4 weeks later the saline infusion.

Drug: IntralipidDrug: Saline

Saline Infusion, then Intralipid

SHAM COMPARATOR

Participants in this arm will first receive a saline infusion. Then 4 weeks later the lipid infusion.

Drug: IntralipidDrug: Saline

Interventions

IntralipidDRUG

0.55 ml/kg/h

Also known as: Liposyn
Intralipid Infusion, then SalineSaline Infusion, then Intralipid
SalineDRUG

0.55 ml/kg/h for

Intralipid Infusion, then SalineSaline Infusion, then Intralipid

Eligibility Criteria

Age18 Years - 45 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64)

You may qualify if:

  • Healthy
  • Sedentary
  • Normal glucose tolerance
  • BMI \<25 kg/m2

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Pennington Biomedical Research Center

Baton Rouge, Louisiana, 70808, United States

Location

Related Publications (1)

  • Axelrod CL, Fealy CE, Erickson ML, Davuluri G, Fujioka H, Dantas WS, Huang E, Pergola K, Mey JT, King WT, Mulya A, Hsia D, Burguera B, Tandler B, Hoppel CL, Kirwan JP. Lipids activate skeletal muscle mitochondrial fission and quality control networks to induce insulin resistance in humans. Metabolism. 2021 Aug;121:154803. doi: 10.1016/j.metabol.2021.154803. Epub 2021 Jun 4.

    PMID: 34090870DERIVED

MeSH Terms

Conditions

Insulin Resistance

Interventions

soybean oil, phospholipid emulsionsafflower oil, soybean oil, lecithin emulsionSodium Chloride

Condition Hierarchy (Ancestors)

HyperinsulinismGlucose Metabolism DisordersMetabolic DiseasesNutritional and Metabolic Diseases

Intervention Hierarchy (Ancestors)

ChloridesHydrochloric AcidChlorine CompoundsInorganic ChemicalsSodium Compounds

Study Officials

  • John P Kirwan, Ph.D.

    Pennington Biomedical Research Center

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
early phase 1
Allocation
RANDOMIZED
Masking
NONE
Purpose
BASIC SCIENCE
Intervention Model
CROSSOVER
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Executive Director

Study Record Dates

First Submitted

February 18, 2016

First Posted

March 3, 2016

Study Start

July 1, 2016

Primary Completion

May 1, 2021

Study Completion

May 1, 2021

Last Updated

July 27, 2021

Record last verified: 2021-07

Data Sharing

IPD Sharing
Will not share

Locations

US(1)