Postprandial Lipidemia After a Meal With Different Types of Fat, Estrogen Treatment, Age and Gender in Healthy Subjects
Primary Purpose
Menopause
Status
Unknown status
Phase
Not Applicable
Locations
Denmark
Study Type
Interventional
Intervention
Estrogens
Placebo
Sponsored by
About this trial
This is an interventional basic science trial for Menopause focused on measuring glucose, cholesterol, estrogen, gender, age
Eligibility 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
Sites / Locations
- Gynecology Dept. Herning Hospital
Arms of the Study
Arm 1
Arm 2
Arm 3
Arm 4
Arm 5
Arm Type
Active Comparator
No Intervention
No Intervention
No Intervention
Placebo Comparator
Arm Label
Estrogens in menopausal women
Menopausal men
Elderly women
Elderly men
Placebo in menopausal women
Arm Description
Crossover of estrogens or placebo in random order, either 2 mg estradiol or placebo in three months in random sequence, age span 45-55
comparative to menopausal women, age span 45-55
comparative to menopausal women, age span 65-80
comparative to menopausal women, age span 65-80
Crossover of estrogen or placebo in random order, either 2 mg estrogen or placebo in three months in random sequence, age span 45-55
Outcomes
Primary Outcome Measures
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
Secondary Outcome Measures
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
Full Information
NCT ID
NCT02383823
First Posted
February 16, 2015
Last Updated
December 12, 2017
Sponsor
Herning Hospital
Collaborators
Sygehus Lillebaelt
1. Study Identification
Unique Protocol Identification Number
NCT02383823
Brief Title
Postprandial Lipidemia After a Meal With Different Types of Fat, Estrogen Treatment, Age and Gender in Healthy Subjects
Official Title
Postprandial Lipidemia and Glucose Metabolism After a Meal With Different Types of Fat, Estrogen Treatment, Age and Gender in Healthy Subjects
Study Type
Interventional
2. Study Status
Record Verification Date
December 2017
Overall Recruitment Status
Unknown status
Study Start Date
August 2019 (Anticipated)
Primary Completion Date
December 2020 (Anticipated)
Study Completion Date
December 2020 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Herning Hospital
Collaborators
Sygehus Lillebaelt
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No
5. Study Description
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.
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).
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Menopause
Keywords
glucose, cholesterol, estrogen, gender, age
7. Study Design
Primary Purpose
Basic Science
Study Phase
Not Applicable
Interventional Study Model
Crossover Assignment
Masking
ParticipantCare Provider
Allocation
Randomized
Enrollment
64 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
Estrogens in menopausal women
Arm Type
Active Comparator
Arm Description
Crossover of estrogens or placebo in random order, either 2 mg estradiol or placebo in three months in random sequence, age span 45-55
Arm Title
Menopausal men
Arm Type
No Intervention
Arm Description
comparative to menopausal women, age span 45-55
Arm Title
Elderly women
Arm Type
No Intervention
Arm Description
comparative to menopausal women, age span 65-80
Arm Title
Elderly men
Arm Type
No Intervention
Arm Description
comparative to menopausal women, age span 65-80
Arm Title
Placebo in menopausal women
Arm Type
Placebo Comparator
Arm Description
Crossover of estrogen or placebo in random order, either 2 mg estrogen or placebo in three months in random sequence, age span 45-55
Intervention Type
Drug
Intervention Name(s)
Estrogens
Other Intervention Name(s)
Estradiol
Intervention Description
Crossover study of estrogen or placebo in random order in menopausal women
Intervention Type
Other
Intervention Name(s)
Placebo
Intervention Description
Crossover study of placebo or estrogen in random order in menopausal women
Primary Outcome Measure Information:
Title
Postprandial lipidemia
Description
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
Time Frame
Three months of estrogen treatment
Secondary Outcome Measure Information:
Title
Postprandial glucose and insulin
Description
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
Time Frame
Three months of estrogen treatment
10. Eligibility
Sex
All
Minimum Age & Unit of Time
45 Years
Maximum Age & Unit of Time
80 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility 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
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Finn F Lauszus, MD, PhD
Phone
+4578434614
Email
finlau@rm.dk
First Name & Middle Initial & Last Name or Official Title & Degree
Ole W Rasmussen, MD,DrMedScie
Phone
+4586523654
Email
olew.rasmussen@dadlnet.dk
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Finn F Lauszus, MD,PhD
Organizational Affiliation
Herning Hospital, Denmark
Official's Role
Principal Investigator
Facility Information:
Facility Name
Gynecology Dept. Herning Hospital
City
Herning
ZIP/Postal Code
7400
Country
Denmark
12. IPD Sharing Statement
Plan to Share IPD
No
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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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