Clinical trial

Role of Fatty Acid Oxidation Defects in Insulin Sensitivity

Name

OHSU11258

Description

The purpose of this study is to learn more about what causes insulin resistance. It has been suggested that proper breakdown of fat into energy (oxidation) in the body is important to allow insulin to keep blood sugar in the normal range. The investigators want to know if having one of the fatty acid oxidation disorders could have an influence on insulin action. Fatty acid oxidation disorders are genetic disorders that inhibit one of the enzymes that converts fat into energy. The investigators will study both normal healthy people and people with a long-chain fatty acid oxidation disorder.

Trial arms

Trial start

2016-02-01

Estimated PCD

2021-01-01

Trial end

2021-03-01

Status

Completed

Treatment

Intralipid/Heparin

Co-infusion of intralipid and heparin solutions during a hyperinsulinemic euglycemic clamp

Arms:

intralipid Control, intralipid FAOD

Glycerol/Saline

Co-infusion of a glycerol/saline solutions during a hyperinsulinemic euglycemic clamp

Arms:

glycerol/saline Control, glycerol/saline FAOD

Hyperinsulinemic euglycemic clamp

Infusion of insulin at at 40 mU/m2/min for 5 hours. Blood glucose will be monitored every 5 min during the insulin infusion and euglycemia will be maintained throughout the clamp by infusing 20% dextrose at a variable rate.

Arms:

glycerol/saline Control, glycerol/saline FAOD, intralipid Control, intralipid FAOD

Size

Primary endpoint

Glucose Disposal Rate (Rd)- the Rate of Glucose Infusion to Maintain Euglycemia During Steady State Insulin Infusion in mg/Min

Calculated during the last 30 minutes of a 300 minute clamp.

Eligibility criteria

Inclusion Criteria: * confirmed diagnosis of VLCAD, LCHAD, TFP or MCAD deficiency or same gender, age and BMI as a subject with a fatty acid oxidation disorder * ability to travel to Oregon Health \& Science University, Portland, Oregon * ability and willingness to complete the protocol Exclusion Criteria: * hemoglobin \<10g/dl, international normalized ratio (INR) \>1.2 Prothrombin time (PTT) \>36 sec, Platelets \<150K/mm3 * pregnant or lactating females * endocrine disorder such as diabetes or untreated thyroid disease * cardiovascular disease or elevated plasma lipids * regularly taking meds that strongly affect bleeding, bruising or platelets

Protocol

{'studyType': 'INTERVENTIONAL', 'phases': ['NA'], 'designInfo': {'allocation': 'RANDOMIZED', 'interventionModel': 'CROSSOVER', 'primaryPurpose': 'BASIC_SCIENCE', 'maskingInfo': {'masking': 'NONE'}}, 'enrollmentInfo': {'count': 41, 'type': 'ACTUAL'}}

Updated at

2024-01-30

1 organization

3 products

7 indications

Organization

Oregon Health and Science University

Product

Intralipid/Heparin

Indication

Very Long-chain Acyl-CoA Dehydrogenase Deficiency

Indication