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Trial record 25 of 762 for:    Area Under Curve AND meal

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

Tracking Information
First Submitted Date  ICMJE February 16, 2015
First Posted Date  ICMJE March 9, 2015
Last Update Posted Date December 13, 2017
Estimated Study Start Date  ICMJE August 2019
Estimated Primary Completion Date December 2020   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: March 3, 2015)
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
Original Primary Outcome Measures  ICMJE Same as current
Change History Complete list of historical versions of study NCT02383823 on ClinicalTrials.gov Archive Site
Current Secondary Outcome Measures  ICMJE
 (submitted: March 3, 2015)
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
Original Secondary Outcome Measures  ICMJE Same as current
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Postprandial Lipidemia After a Meal With Different Types of Fat, Estrogen Treatment, Age and Gender in Healthy Subjects
Official Title  ICMJE Postprandial Lipidemia and Glucose Metabolism After a Meal With Different Types of Fat, Estrogen Treatment, Age and Gender in Healthy Subjects
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).

Study Type  ICMJE Interventional
Study Phase  ICMJE Not Applicable
Study Design  ICMJE Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: Double (Participant, Care Provider)
Primary Purpose: Basic Science
Condition  ICMJE Menopause
Intervention  ICMJE
  • Drug: Estrogens
    Crossover study of estrogen or placebo in random order in menopausal women
    Other Name: Estradiol
  • Other: Placebo
    Crossover study of placebo or estrogen in random order in menopausal women
Study Arms  ICMJE
  • 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
    Intervention: Drug: Estrogens
  • 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
    Intervention: Other: Placebo
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Not yet recruiting
Estimated Enrollment  ICMJE
 (submitted: March 3, 2015)
64
Original Estimated Enrollment  ICMJE Same as current
Estimated Study Completion Date  ICMJE December 2020
Estimated Primary Completion Date December 2020   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 45 Years to 80 Years   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE Yes
Contacts  ICMJE
Contact: Finn F Lauszus, MD, PhD +4578434614 finlau@rm.dk
Contact: Ole W Rasmussen, MD,DrMedScie +4586523654 olew.rasmussen@dadlnet.dk
Listed Location Countries  ICMJE Denmark
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT02383823
Other Study ID Numbers  ICMJE M-2104-99
Has Data Monitoring Committee No
U.S. FDA-regulated Product
Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
IPD Sharing Statement  ICMJE
Plan to Share IPD: No
Responsible Party Finn Friis Lauszus, Herning Hospital
Study Sponsor  ICMJE Herning Hospital
Collaborators  ICMJE Sygehus Lillebaelt
Investigators  ICMJE
Principal Investigator: Finn F Lauszus, MD,PhD Herning Hospital, Denmark
PRS Account Herning Hospital
Verification Date December 2017

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP