Postprandial Lipidemia After a Meal With Different Types of Fat, Estrogen Treatment, Age and Gender in Healthy Subjects

Postprandial Lipidemia and Glucose Metabolism After a Meal With Different Types of Fat, Estrogen Treatment, Age and Gender in Healthy Subjects

The study examines the effect of hormone replacement in postmenopausal women compared to men, 55 years of age, and in the elderly without hormone replacement of both sexes. The lipid and glucose metabolism is evaluated during treatment and placebo with a meal with mashed potatoes and different types of fat. Glucose, insulin, triglyceride, total cholesterol, LDL and HDL cholesterol, free fatty acids and coagulation parameters are measured.

During menopause the women reduce their levels of estrogen and their risk of cardiovascular disease rises to the men's level. This effect on mortality and morbidity can probably be reduced by hormone therapy.

Study Overview

• Status: Unknown
• Conditions: Menopause
• Intervention / Treatment: Drug: Estrogens; Other: Placebo

Detailed Description

The experiment illustrates the gender, age and estrogen influence the acute metabolic responses after meal consisting of mashed potatoes added different types of fat. The reason is that the distribution of macronutrients are often not equal to the ideal and fat intake in Western countries is well above the recommended maximum of 30%. A high fat intake -especially saturated fat -increases the risk of ischemic heart disease significantly and HDL cholesterol levels are determined by the postprandial lipid response. The negative correlation between HDL cholesterol and ischemic heart disease can apparently be attributed to a strong positive correlation between postprandial lipidemia and ischemic heart disease.

Diet has an important role in both the development and treatment of diseases such as type 2 diabetes, elevated blood cholesterol, and obesity. It is recommended today to eat a high-carbohydrate and low-fat diet with reduced energy in these patients. Postprandial lipid in the blood after fat meals expected to be gender-specific, since men's total and LDL-cholesterol and triglycerides are higher than in women of childbearing age. Menopause reduces women's estrogen levels and increase their risk of cardiovascular disease to men's level. This effect on morbidity and mortality is influenced probably by hormone replacement. What influence it has on the postprandial responses is uncertain. The haemostatic system plays an important role in the development of ischemic heart disease and in acute conditions such as acute myocardial infarction, unstable angina, and sudden cardiac death. Fat-rich meals induces an acute activation of coagulation factors and postprandial lipid levels in the blood are essential to the development of atherosclerosis and coagulation activation 4 to 8 hours after a meal. The influence of gender, age, estrogen and different fat types of these conditions are not yet fully elucidated. The investigators believe it is important to investigate the effect of addition of different types of fat to a starchy meal on blood glucose, insulin and lipid levels in healthy subjects, since the metabolic responses today considered closely associated to the development of atherosclerosis and type 2 diabetes.

The investigators therefore wish to investigate the effect of hormones in postmenopausal women compared to men and to assess the effect of age in both sexes of acute metabolic responses by examining the age groups 45-55 (40 women in total in 5 different hormone treatments and 8 men) and 65-80 years (16 in total, 8 of each gender).

The effect is assessed on glycemic response, insulin, triglyceride, total cholesterol, LDL and HDL cholesterol, apo-lipoprotein, free fatty acids and coagulation parameters (von Willebrand factor, Factor VII, Factor VIIa, Plasminogen activator inhibitor-1, fibrinogen, tissue thromboplastin, fibrin).

• Study Type: Interventional
• Enrollment (Anticipated): 64
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Finn F Lauszus, MD, PhD; Phone Number: +4578434614; Email: finlau@rm.dk
• Study Contact Backup: Name: Ole W Rasmussen, MD,DrMedScie; Phone Number: +4586523654; Email: olew.rasmussen@dadlnet.dk

Study Locations

• Denmark
  • Herning, Denmark, 7400
    • Gynecology Dept. Herning Hospital

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 45 years to 80 years (Adult, Older Adult)
• Accepts Healthy Volunteers: Yes
• Genders Eligible for Study: All

Description

Inclusion Criteria:

• Men, age 45-55
• Men age 65-80
• Women age 45-55: The menopausal women's follicle stimulating hormone and luteinizing hormone levels should be above 40 nmol/l
• Women age 65-80

Exclusion Criteria:

• hypercholesterolemia,
• hypertension,
• substance abuse or alcohol abuse
• recognized renal, hepatic, cardiac and metabolic disorders,
• thromboembolic diseases,
• active cancer of the uterus or breast or
• other hormone replacement therapy.
• If pronounced side effects of hormone treatment, the subject is omitted from the trial

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Basic Science
• Allocation: Randomized
• Interventional Model: Crossover Assignment
• Masking: Double

Number of Arms

5

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Active Comparator: Estrogens in menopausal women; Crossover of estrogens or placebo in random order, either 2 mg estradiol or placebo in three months in random sequence, age span 45-55	Drug: Estrogens; Crossover study of estrogen or placebo in random order in menopausal women; Other Names: Estradiol
No Intervention: Menopausal men; comparative to menopausal women, age span 45-55
No Intervention: Elderly women; comparative to menopausal women, age span 65-80
No Intervention: Elderly men; comparative to menopausal women, age span 65-80
Placebo Comparator: Placebo in menopausal women; Crossover of estrogen or placebo in random order, either 2 mg estrogen or placebo in three months in random sequence, age span 45-55	Other: Placebo; Crossover study of placebo or estrogen in random order in menopausal women

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Postprandial lipidemia	Comparison of area under curve of lipids after estrogen treatment with no treatment, gender, and age: Cholesterol, LDL; HDL, TG; FFA: Unit: mmol/L*480 min	Three months of estrogen treatment

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Postprandial glucose and insulin	Comparison of area under curve of glucose (mmol/L * 480 min) and insulin (micro-equivalents/L* 480 min) after estrogen treatment with no treatment, gender, and age	Three months of estrogen treatment

Collaborators and Investigators

• Sponsor: Herning Hospital
• Collaborators: Sygehus Lillebaelt
• Investigators: Principal Investigator: Finn F Lauszus, MD,PhD, Herning Hospital, Denmark

Study record dates

Study Major Dates

• Study Start (Anticipated): August 1, 2019
• Primary Completion (Anticipated): December 1, 2020
• Study Completion (Anticipated): December 1, 2020

Study Registration Dates

• First Submitted: February 16, 2015
• First Submitted That Met QC Criteria: March 3, 2015
• First Posted (Estimate): March 9, 2015

Study Record Updates

• Last Update Posted (Actual): December 13, 2017
• Last Update Submitted That Met QC Criteria: December 12, 2017
• Last Verified: December 1, 2017

More Information

Terms related to this study

• Keywords: glucose, cholesterol, estrogen, gender, age
• Additional Relevant MeSH Terms: Metabolic Diseases; Lipid Metabolism Disorders; Dyslipidemias; Hyperlipidemias; Physiological Effects of Drugs; Hormones; Hormones, Hormone Substitutes, and Hormone Antagonists; Estradiol; Estrogens
• Other Study ID Numbers: M-2104-99

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