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

NCT02383823 | Withdrawn

• 1 other identifier: M-2104-99
• Study Type: interventional
• Target: N/A
• Locations: 1 country
• Sites: 1

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.

Conditions

Menopause

Keywords

glucose, cholesterol, estrogen, gender, age

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (1)

• Postprandial glucose and insulin

  Three months of estrogen treatment

Study Arms (5)

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

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

Other: Placebo

Interventions

Estrogens DRUG

Crossover study of estrogen or placebo in random order in menopausal women

Also known as: Estradiol

Estrogens in menopausal women

Placebo OTHER

Crossover study of placebo or estrogen in random order in menopausal women

Placebo in menopausal women

Eligibility Criteria

• Age: 45 Years - 80 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Herning Hospital: lead
• Sygehus Lillebaelt: collaborator

Study Sites (1)

Gynecology Dept. Herning Hospital

Herning, 7400, Denmark

Location

MeSH Terms

Conditions

Coitus

Interventions

Estrogens; Estradiol

Condition Hierarchy (Ancestors)

Sexual Behavior; Behavior

Intervention Hierarchy (Ancestors)

Hormones; Hormones, Hormone Substitutes, and Hormone Antagonists; Physiological Effects of Drugs; Pharmacologic Actions; Chemical Actions and Uses; Estrenes; Estranes; Steroids; Fused-Ring Compounds; Polycyclic Compounds; Estradiol Congeners; Gonadal Steroid Hormones; Gonadal Hormones

Study Officials

• Finn F Lauszus, MD,PhD

  Herning Hospital, Denmark

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, CARE PROVIDER
• Purpose: BASIC SCIENCE
• Intervention Model: CROSSOVER
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Associate Professor, Research Specialist, Senoir Consultant

Study Record Dates

• First Submitted: February 16, 2015
• First Posted: March 9, 2015
• Study Start: August 10, 2019
• Primary Completion: December 10, 2020
• Study Completion: December 10, 2020
• Last Updated: October 16, 2024

Record last verified: 2024-10

Data Sharing

• IPD Sharing: Will not share

Locations

DK (1)