Does Class of Dietary Fat Affect Insulin Resistance?

This study is ongoing, but not recruiting participants.
Sponsor:
Information provided by (Responsible Party):
Robert.H.Nelson, Mayo Clinic
ClinicalTrials.gov Identifier:
NCT01541592
First received: February 21, 2012
Last updated: December 17, 2013
Last verified: December 2013
  Purpose

It has been shown that intravenous fatty acids given to normal volunteers in the form of heparin and lipid emulsions will cause insulin resistance in a matter of a few hours. It is not known if this same phenomenon can be demonstrated with oral fat. The investigators are specifically interested in whether or not there are differences in the induction of insulin resistance between the 3 main classes of fatty acids (saturated, monounsaturated and polyunsaturated).

The investigators also plan to evaluate endothelial dysfunction and blood pressure; both of which frequently accompany insulin resistance.


Condition Intervention
Insulin Resistance
Other: Dietary fat

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Basic Science
Official Title: Insulin Resistance and Dietary Fat

Resource links provided by NLM:


Further study details as provided by Mayo Clinic:

Primary Outcome Measures:
  • Change in Insulin Sensitivity from Baseline at Two Weeks [ Time Frame: Average of 2 weeks. ] [ Designated as safety issue: No ]
    Insulin sensitivity will be measured twice (once at baseline following a nasoduodenal infusion of saline for 6 hours; two weeks later following a nasoduodenal infusion of a vegetable oil high in one of 3 fatty acids for 6 hours) using a euglycemic, hyperinsulinemic clamp as described by R. DeFronzo. The actual measurement is expressed as a glucose infusion rate.


Secondary Outcome Measures:
  • Change in Endothelial Function from Baseline at Two Weeks [ Time Frame: Average of two weeks ] [ Designated as safety issue: No ]
    Endothelial function will be measured by measuring the dilation of the brachial artery in the elbow following occlusion by a blood pressure cuff, which is then released. The actual measurement involves use of ultrasound by an investigator experienced with this technique.

  • Change in Systolic Blood Pressure at Two Weeks [ Time Frame: Average of two weeks ] [ Designated as safety issue: No ]
    Blood pressure will be measured using a standard automated blood pressure cuff. The measurements will be taken several times during each study day.


Estimated Enrollment: 24
Study Start Date: March 2012
Estimated Study Completion Date: December 2013
Estimated Primary Completion Date: December 2013 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Active Comparator: Saturated fat
Palm oil (rich in the saturated fat palmitate)
Other: Dietary fat
On the study day, each participant will receive 100 grams of a randomly assigned fat via a nasoduodenal tube. The oil will be infused at a rate of ~1 tablespoon per hour so that the total infusion time will be 6 hours.
Active Comparator: Monounsaturated fat
Olive oil (rich in the monounsaturated fat oleate)
Other: Dietary fat
On the study day, each participant will receive 100 grams of a randomly assigned fat via a nasoduodenal tube. The oil will be infused at a rate of ~1 tablespoon per hour so that the total infusion time will be 6 hours.
Active Comparator: Polyunsaturated fat
Safflower oil (rich in the polyunsaturated fat linoleate)
Other: Dietary fat
On the study day, each participant will receive 100 grams of a randomly assigned fat via a nasoduodenal tube. The oil will be infused at a rate of ~1 tablespoon per hour so that the total infusion time will be 6 hours.

Detailed Description:

Type 2 Diabetes and cardiovascular disease are closely linked. A common abnormality in both conditions is insulin resistance. The primary cause of insulin resistance in not known. A significant question is what dietary components contribute to the development of insulin resistance. Based on epidemiologic data, it seems that the type of dietary fat is a significant contributor to the development of insulin resistance. However, some researchers argue that the main determinant is total amount of fat, not the composition.

This study is intended to determine if the main types of fat (saturated, monounsaturated and polyunsaturated) ingested over a short time can cause insulin resistance in lean, healthy people. It has been demonstrated that 6 hours of intravenous fat infused into lean, healthy subjects can result in insulin resistance, as well as blood pressure elevation and endothelial dysfunction. Whether this is so with oral fat is not known. The question is important because there is debate about whether the type of fat is as important as the quantity of fat in a person's daily diet. Settling this debate will enhance the ability of health care personnel to determine the optimal dietary recommendations.

This study will make use of a high fat diet consisting of vegetable oils high in the 3 main fatty acids in plasma (palmitate, oleate and linoleate). Because large fat loads can cause intestinal discomfort, a feeding tube will be used to bypass the stomach. The 3 oils will be assigned randomly following a base line study with saline 2 weeks prior to the intervention. Our primary endpoint is insulin resistance, which will be measured by a euglycemic, hyperinsulinemic clamp. Secondary measures will include changes in blood pressure and in vascular reactivity as measured by ultrasound after brief occlusion of a forearm vessel. The changes will be compared to baseline and to the other 2 groups.

  Eligibility

Ages Eligible for Study:   18 Years to 40 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion Criteria:

  • Lean,healthy adults 18 - 40
  • No chronic medications (birth control pills allowed)
  • Weight stable
  • Normal fasting labs performed at screening
  • Body mass index ≤ 25 kg/M^2 .

Exclusion Criteria:

  • Insulin dependent diabetes
  • Thyroid disease
  • History of diabetes or heart disease
  • History of type 2 diabetes in parent or sibling
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01541592

Locations
United States, Minnesota
Mayo Clinic in Rochester
Rochester, Minnesota, United States, 55905
Sponsors and Collaborators
Mayo Clinic
Investigators
Principal Investigator: Robert Nelson, MD Mayo Clinic
  More Information

No publications provided

Responsible Party: Robert.H.Nelson, Assistant Professor of Family Medicine and Medicine, Mayo Clinic
ClinicalTrials.gov Identifier: NCT01541592     History of Changes
Other Study ID Numbers: 11-000179
Study First Received: February 21, 2012
Last Updated: December 17, 2013
Health Authority: United States: Institutional Review Board

Keywords provided by Mayo Clinic:
Insulin resistance
Endothelial dysfunction
saturated fat
monounsaturated fat
polyunsaturated fat

Additional relevant MeSH terms:
Insulin Resistance
Hyperinsulinism
Glucose Metabolism Disorders
Metabolic Diseases
Insulin
Hypoglycemic Agents
Physiological Effects of Drugs
Pharmacologic Actions

ClinicalTrials.gov processed this record on April 16, 2014