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

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ClinicalTrials.gov Identifier: NCT02383823
Recruitment Status : Not yet recruiting
First Posted : March 9, 2015
Last Update Posted : December 13, 2017
Sponsor:
Collaborator:
Sygehus Lillebaelt
Information provided by (Responsible Party):
Finn Friis Lauszus, Herning Hospital

Brief Summary:

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.


Condition or disease Intervention/treatment Phase
Menopause Drug: Estrogens Other: Placebo Not Applicable

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  (Clinical Trial)
Estimated Enrollment : 64 participants
Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: Double (Participant, Care Provider)
Primary Purpose: Basic Science
Official Title: Postprandial Lipidemia and Glucose Metabolism After a Meal With Different Types of Fat, Estrogen Treatment, Age and Gender in Healthy Subjects
Estimated Study Start Date : August 2019
Estimated Primary Completion Date : December 2020
Estimated Study Completion Date : December 2020

Resource links provided by the National Library of Medicine


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 Name: 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




Primary Outcome Measures :
  1. Postprandial lipidemia [ Time Frame: Three months of estrogen treatment ]
    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


Secondary Outcome Measures :
  1. Postprandial glucose and insulin [ Time Frame: Three months of estrogen treatment ]
    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



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Ages Eligible for Study:   45 Years to 80 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Criteria

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02383823


Contacts
Contact: Finn F Lauszus, MD, PhD +4578434614 finlau@rm.dk
Contact: Ole W Rasmussen, MD,DrMedScie +4586523654 olew.rasmussen@dadlnet.dk

Locations
Denmark
Gynecology Dept. Herning Hospital
Herning, Denmark, 7400
Sponsors and Collaborators
Herning Hospital
Sygehus Lillebaelt
Investigators
Principal Investigator: Finn F Lauszus, MD,PhD Herning Hospital, Denmark

Responsible Party: Finn Friis Lauszus, Associate Professor, Research Specialist, Senoir Consultant, Herning Hospital
ClinicalTrials.gov Identifier: NCT02383823     History of Changes
Other Study ID Numbers: M-2104-99
First Posted: March 9, 2015    Key Record Dates
Last Update Posted: December 13, 2017
Last Verified: December 2017
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No

Keywords provided by Finn Friis Lauszus, Herning Hospital:
glucose, cholesterol, estrogen, gender, age

Additional relevant MeSH terms:
Hyperlipidemias
Dyslipidemias
Lipid Metabolism Disorders
Metabolic Diseases
Estradiol
Estrogens
Hormones
Hormones, Hormone Substitutes, and Hormone Antagonists
Physiological Effects of Drugs