NCT02233283

Brief Summary

Undernutrition has a known and well recognized negative impact on reproductive hormones, and ultimately fertility. In contrast, much less is known regarding the potential effects of overnutrition on the same hormones. Epidemiological data suggest that overnutrition might have a deleterious impact as well on the fertile potential of affected women, but very little is known about the mechanisms implicated. Such knowledge may be of importance, given the increasing prevalence of overweight and obesity worldwide.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
9

participants targeted

Target at below P25 for not_applicable

Timeline
Completed

Started Jan 2014

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

January 1, 2014

Completed
7 months until next milestone

First Submitted

Initial submission to the registry

July 21, 2014

Completed
2 months until next milestone

First Posted

Study publicly available on registry

September 8, 2014

Completed
3 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 1, 2014

Completed
6 months until next milestone

Study Completion

Last participant's last visit for all outcomes

June 1, 2015

Completed
Last Updated

August 21, 2015

Status Verified

August 1, 2015

Enrollment Period

11 months

First QC Date

July 21, 2014

Last Update Submit

August 20, 2015

Conditions

Female Reproductive System Disorder

Keywords

LH pulsatilityInsulin sensitivityMetabolismhypercaloric feeding

Outcome Measures

Primary Outcomes (1)

  • Luteinizing hormone secretion

    The pulsatility of LH will be assessed by measuring LH levels in blood sample obtained every ten minutes over the entire study period (12 hours).

    Every ten minutes for 10 hours

Secondary Outcomes (1)

  • Insulin sensitivity

    10 hours

Study Arms (4)

Hypercaloric diet and basal

ACTIVE COMPARATOR

Volunteers fed a hypercaloric diet for one month will be submitted to a fasting period of ten hours duration

Other: Hypercaloric dietOther: Basal

Hypercaloric diet and clamp

EXPERIMENTAL

Volunteers fed a hypercaloric diet for one month will be submitted to a hyperinsulinemic and euglycemic clamp of ten hours duration

Other: ClampOther: Hypercaloric diet

Isocaloric diet and basal

ACTIVE COMPARATOR

Volunteers fed a isocaloric diet for one month will be submitted to a fasting period of ten hours duration

Other: BasalOther: Isocaloric diet

Isocaloric diet and clamp

EXPERIMENTAL

Volunteers fed a isocaloric diet for one month will be submitted to a hyperinsulinemic and euglycemic clamp of ten hours duration

Other: ClampOther: Isocaloric diet

Interventions

ClampOTHER

Volunteers will be submitted to hyperinsulinemic, euglycemic clamp studies of 10 hours duration.

Also known as: Hyperinsulinemic and euglycemic clamp study
Hypercaloric diet and clampIsocaloric diet and clamp
Hypercaloric dietOTHER

Hypercaloric diet will be conducted during one month, and designed to provide 30% excess in calories compared to daily requirements. It will consist in a high fat, high carbohydrates diet.

Also known as: Overfeeding
Hypercaloric diet and basalHypercaloric diet and clamp
BasalOTHER

Keeping the volunteers in the fasting state overnight and for the entire duration of the experiment (10 hours)

Also known as: Fasting
Hypercaloric diet and basalIsocaloric diet and basal
Isocaloric dietOTHER

Isocaloric diet will conducted for one month, and designed to provide the calculated daily energy needs

Also known as: Controlled diet
Isocaloric diet and basalIsocaloric diet and clamp

Eligibility Criteria

Age18 Years - 30 Years
Sexfemale
Healthy VolunteersYes
Age GroupsAdult (18-64)

You may qualify if:

  • normally cycling young (between 18 and 30 yo) female, with a BMI between 20 and 25 kg/m2.

You may not qualify if:

  • Personal history of endocrine dysfunction (any kind)
  • Hormonal contraception
  • Pregnancy
  • Food allergy (any kind)
  • Intense physical activity (\>4 hrs/week)
  • Smoking

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Clinical Research Center, University Hospital

Lausanne, Canton of Vaud, 1011, Switzerland

Location

Related Publications (1)

  • van Leckwyck M, Kong W, Burton KJ, Amati F, Vionnet N, Pralong FP. Decreasing Insulin Sensitivity in Women Induces Alterations in LH Pulsatility. J Clin Endocrinol Metab. 2016 Aug;101(8):3240-9. doi: 10.1210/jc.2016-1727. Epub 2016 Jun 16.

    PMID: 27309039DERIVED

MeSH Terms

Conditions

Insulin Resistance

Interventions

ConstrictionAngptl4 protein, mouse

Condition Hierarchy (Ancestors)

HyperinsulinismGlucose Metabolism DisordersMetabolic DiseasesNutritional and Metabolic Diseases

Intervention Hierarchy (Ancestors)

Investigative Techniques

Study Officials

  • Francois P Pralong, MD

    Centre Hospitalier Universitaire Vaudois

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NON RANDOMIZED
Masking
NONE
Purpose
BASIC SCIENCE
Intervention Model
CROSSOVER
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Full professor and Head, Service of Endocrinology, Diabetology and Metabolism

Study Record Dates

First Submitted

July 21, 2014

First Posted

September 8, 2014

Study Start

January 1, 2014

Primary Completion

December 1, 2014

Study Completion

June 1, 2015

Last Updated

August 21, 2015

Record last verified: 2015-08

Locations

CH(1)