MenopauseNCT02383823
Postprandial Lipidemia After a Meal With Different Types of Fat, Estrogen Treatment, Age and Gender in Healthy Subjects
A study testing Estrogens in people with Menopause, run by Herning Hospital at 1 site in Denmark.
Trial 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. Read more about this study
- Who is it for?
- Ages 45 to 80 yearsHealthy volunteers can take part
- Conditions the study is for
- Menopause
- What is being tested?
- Estrogens
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 0 participants
- Where
- 1 siteDenmark
- Study dates
- 10 Aug 2019to 10 Dec 2020
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 45 to 80 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
About this study
Official title: 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.
Read the 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).
- Conditions
- Menopause
- Being tested
- Estrogens, Placebo
- Keywords
- glucose, cholesterol, estrogen, gender, age
- Medical subject headings
- Coitus
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
EstrogensDrug
Also called Estradiol
Crossover study of estrogen or placebo in random order in menopausal women
PlaceboOther
Crossover study of placebo or estrogen in random order in menopausal women
| Study group | Role | What they receive |
|---|---|---|
| Estrogens in menopausal women | Active comparator | Crossover of estrogens or placebo in random order, either 2 mg estradiol or placebo in three months in random sequence, age span 45-55 Receives: Drug: Estrogens |
| Menopausal men | No intervention | comparative to menopausal women, age span 45-55 |
| Elderly women | No intervention | comparative to menopausal women, age span 65-80 |
| Elderly men | No intervention | comparative to menopausal women, age span 65-80 |
| Placebo in menopausal women | Placebo comparator | Crossover of estrogen or placebo in random order, either 2 mg estrogen or placebo in three months in random sequence, age span 45-55 Receives: Other: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
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
Measured: Three months of estrogen treatment
Secondary outcomes (1)
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
Measured: Three months of estrogen treatment
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted9 Mar 2015 (estimated)
- Study start10 Aug 2019
- Primary completion10 Dec 2020
- Study completion10 Dec 2020
Why it stopped: Never started the inclusion
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for MenopauseStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Basic science
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Double blind
- Who is masked
- Participant, Care provider
- Enrolment
- 0 participants (actual)
Sponsor and investigators
- Lead sponsor
- Herning Hospital
- Sponsor type
- University, hospital or other
- Collaborators
- Sygehus Lillebaelt
- Responsible party
- Principal investigator, Finn Lauszus, Herning Hospital
- Investigators
- Finn F Lauszus, MD,PhD, Principal investigator, Herning Hospital, Denmark
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02383823
- Sponsor's protocol ID
- M-2104-99
- Status last verified
- Oct 2024
- First submitted
- 16 Feb 2015
- Last updated
- 16 Oct 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 16 Oct 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Postprandial Lipidemia and Glucose Metabolism After a Meal With Different Types of Fat, Estrogen Treatment, Age and Gender in Healthy Subjects
- ClinicalTrials.gov ID
- NCT02383823
- Acronym / sponsor ID
- M-2104-99
- Conditions
- Menopause
- Keywords
- glucose, cholesterol, estrogen, gender, age
- Study type
- Interventional
- Recruitment status
- WithdrawnReason stopped: Never started the inclusion
- Enrolment
- 0 participants (actual)
- Lead sponsor
- Herning HospitalUniversity, hospital or other
- Collaborators
- Sygehus Lillebaelt
- Study start
- 10 Aug 2019 (actual)
- Primary completion
- 10 Dec 2020 (actual)
- Study completion
- 10 Dec 2020 (actual)
- First posted
- 9 Mar 2015 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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).
Study design
- Primary purpose
- Basic science
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Double blind (participant, care provider)
- Number of arms
- 5
| Arm | Type | Receives |
|---|---|---|
| Estrogens in menopausal women | Active comparator | Drug: EstrogensCrossover of estrogens or placebo in random order, either 2 mg estradiol or placebo in three months in random sequence, age span 45-55 |
| Menopausal men | No intervention | –comparative to menopausal women, age span 45-55 |
| Elderly women | No intervention | –comparative to menopausal women, age span 65-80 |
| Elderly men | No intervention | –comparative to menopausal women, age span 65-80 |
| Placebo in menopausal women | Placebo comparator | Other: PlaceboCrossover of estrogen or placebo in random order, either 2 mg estrogen or placebo in three months in random sequence, age span 45-55 |
Who may qualify
- Ages
- 45 to 80 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- 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
Key exclusion criteria (8 listed)
- hypercholesterolemia,
- hypertension,
- substance abuse or alcohol abuse
- recognized renal, hepatic, cardiac and metabolic disorders,
- thromboembolic diseases,
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| EstrogensAlso: EstradiolCrossover study of estrogen or placebo in random order in menopausal women | Drug | Estrogens in menopausal women |
| PlaceboCrossover study of placebo or estrogen in random order in menopausal women | Other | Placebo in menopausal women |
Primary outcome
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
1 secondary outcome
Postprandial glucose and insulin
Time frame: Three months of estrogen treatment
Results and safety
The study was withdrawn before enrolling participants, so there are no results.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 16 Oct 2024.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Finn F Lauszus, MD,PhD principal investigator
Herning Hospital, Denmark
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Estrogens in people with Menopause, run by Herning Hospital at 1 site in Denmark.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 8 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: withdrawn, as of the sponsor's last update on 16 Oct 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Denmark. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study was withdrawn before enrolling participants, so there are no results.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Postprandial lipidemia (time frame: Three months of estrogen treatment). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 16 Oct 2024.