The influence of fat intake, estrogen, age, and gender on postprandial lipds and glucose

Phase 1

Conditions: Healthy volunteers
MedDRA version: 18.0Level: LLTClassification code 10050903Term: Postmenopausal symptomsSystem Organ Class: 100000004872
Therapeutic area: Body processes [G] - Metabolic Phenomena [G03]

Registration Number: EUCTR2015-002326-39-DK

Lead Sponsor: Gynecology Department,Herning Hospital

Brief Summary: Not available

Detailed Description: Not available

Recruitment & Eligibility

Status: Authorised-recruitment may be ongoing or finished

Sex: Female

Target Recruitment: Not specified

Inclusion Criteria

Healthy individuals age 45-55 and 65-80 years of both gender. Only the women age 45-55 are subjected to the estrogen replacement and the intake is randomized to start with either placebo or active substance for these women only. All other groups, i.e. males age 45-55, and both gender age 65-80 act as controls
Are the trial subjects under 18? no
Number of subjects for this age range:
F.1.2 Adults (18-64 years) yes
F.1.2.1 Number of subjects for this age range 40
F.1.3 Elderly (>=65 years) no
F.1.3.1 Number of subjects for this age range

Exclusion Criteria

Person suffering form dumping syndorme, hypercholesterolemia, hypertension, abuse of substance or alcohol, known kidney-, liver-, biliary-, cardiovascular and metabolic diseases, thromboembolic disorders, active cancer of the uterus or breast and other hormone therapy.

Study & Design

Study Type: Interventional clinical trial of medicinal product

Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Main Objective: Describing postprandial effects of hormonal replacement therapy with estrogen-like substances. Lipids and glucose are measured after a standard test meal after 3 months of ingestion of either active substance or placebo;Secondary Objective: Different types of hormone replacement are evaluated for their effect on postprandial lips oga glucose metabolism. Similarly age and gender effects are compared;Primary end point(s): postprandial area under the curve for cholesterols (total, HDL, LDL),triglycerides, and free fatty acids;Timepoint(s) of evaluation of this end point: after 2 years the blood samples will be measured in one batch

Secondary Outcome Measures

Name	Time	Method
Secondary end point(s): postprandial area under the curve for glucose and insulin;Timepoint(s) of evaluation of this end point: after 2 years the blood samples will be measured in one batch