Evaluation of Kisspeptin Glucose-Stimulated Insulin Secre... | NCT04532801

Studies
Evaluation of Kisspeptin Glucose-Stimulated Insulin Secretion With Physiologic Mixed Meal Tolerance

NCT04532801

Sponsor

Stephanie B. Seminara, MD

Status

Withdrawn

Last Update Posted

Aug 1, 2024Actual

Enrollment

0Actual

Phase

Phase 1

Conditions

Insulin
Glucose
Healthy Volunteers
Women
Pregnancy

Interventions

Kisspeptin-10
mixed meal tolerance test

Countries

United States

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Jul 2024

Overall Recruitment Status or Expanded Access Status

Withdrawn

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Interim analysis of data collected under other clinical trials demonstrated planned enrollment was insufficiently powered.

Expanded Access Info

Start Date

Sep 1, 2019Actual

Primary Completion Date

Aug 31, 2024Estimated

Completion Date

Dec 21, 2024Estimated

First Submitted Date

Aug 23, 2020

First Submission Date that Met QC Criteria

Aug 27, 2020

First Posted Date

Aug 31, 2020Actual

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Jul 30, 2024

Last Update Posted Date

Aug 1, 2024Actual

Sponsor/Collaborators Module

Responsible Party, by Official Title

Stephanie B. Seminara, MD, Chief, Reproductive Endocrine Unit; Professor of Medicine, Harvard Medical School; Director, Harvard Reproductive Endocrine Sciences Center, Massachusetts General HospitalSponsor-Investigator

Lead Sponsor

Stephanie B. Seminara, MDOTHER

Collaborators

Not provided

Oversight Module

Has Data Monitoring Committee (DMC)

Yes

Is FDA Regulated Drug

Yes

Is FDA Regulated Device

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

Brief Summary

This study utilizes infusions of kisspeptin in healthy women to isolate the impact of kisspeptin on beta-cell responsivity assessed by the mixed meal tolerance test.

Detailed Description

Assignment: each study subject serves as their own control, and will come in timed to their cycle. The order in which they undergo the kisspeptin or placebo arms is randomized and separated by greater than two weeks to minimize variability and study-specific effects.

Delivery of Interventions:

Prior to each visit, study subjects will be asked to:

eat at least 150 gm carbohydrates per day
refrain from strenuous exercise

On the day of the visit, study subjects will:

eat a standardized meal prepared by the metabolic kitchen in the clinical research center
be observed overnight to ensure a 12-hour fast
have an IV placed, for a 16 hour kisspeptin or placebo infusion
after the 12 hour fast, starting at 8 am in the morning will undergo a mixed meal tolerance test

Design Module

Study Type

Interventional

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Not provided

Target Follow-Up Duration

Not provided

Phases

Phase 1

Interventional Study Design

Allocation

Biospecimen

No data available

No data is available for this block.

Enrollment

0Actual

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
kisspeptin-10	Experimental	kisspeptin infusion	Drug: Kisspeptin-10 Other: mixed meal tolerance test
placebo	Placebo Comparator	placebo	Other: mixed meal tolerance test

Interventions

Name	Type	Description	Arm Group Labels	Other Names
Kisspeptin-10	Drug	kisspeptin-10 IV infusion	kisspeptin-10	kisspeptin

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
Beta-cell responsivity index	Average beta-cell responsivity index derived from mixed meal tolerance data comparing placebo and kisspeptin arms	up to 6 months

Secondary Outcomes

Not provided

Other Outcomes

Measure	Description	Time Frame
Fasting insulin level	Average fasting insulin level comparing placebo and kisspeptin arms	up to 6 months

Eligibility Module

Eligibility Criteria

HISTORY

no personal history of chronic disease, except well controlled thyroid disease
no history of diabetes in a first degree relative, including gestational diabetes
no family or personal history of hyperlipidemia
normal timing of menarche (age 10-14)
normal menstrual cycles (q25-35 days)
no use of contraceptive pills, patches or vaginal rings within last 4 weeks
nulliparous (no history of a pregnancy)
no active illicit drug use
no history of a medication reaction requiring emergency medical care
no difficulty with blood draws
stable weight for previous three months
available for all parts of the study

PHYSICAL

body mass index (18.5-25)
systolic BP < 120mm Hg, diastolic < 80 mm Hg
normal waist circumference (less than 32 inches)

LABORATORY STUDIES: (per Massachusetts General Hospital reference ranges)

fasting LDL cholesterol less than 130 mg/dL
fasting triglycerides less than 150 mg/dL
normal hemoglobin
hemoglobin A1C < 5.7%
blood urea nitrogen, creatinine not elevated
AST, ALT not elevated
negative serum pregnancy test

Accepts Healthy Volunteers

Yes

Sex

Female

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

18 Years

Maximum Age

40 Years

Standard Ages

Adult

Study Population

Not provided

Sampling Method

Not provided

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

Name	Affiliation	Role
Margaret Lippincott, MD	Massachusetts General Hospital	Principal Investigator

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Massachusetts General Hospital		Boston	Massachusetts	02114	United States

IPD Sharing Statement Module

Plan to Share IPD

Description

Not provided

Types

Not provided

Time Frame

Not provided

Access Criteria

Not provided

URL

Not provided

Condition Browse Module

MeSH Terms

ID	Term
D007333	Insulin Resistance

Ancestor Terms

ID	Term
D006946	Hyperinsulinism
D044882	Glucose Metabolism Disorders
D008659	Metabolic Diseases
D009750	Nutritional and Metabolic Diseases

Browse Leaves

Not provided

Browse Branches

Not provided

Intervention Browse Module

MeSH Terms

ID	Term
C106628	KISS1 protein, human
D059648	Kisspeptins

Ancestor Terms

ID	Term
D036341	Intercellular Signaling Peptides and Proteins
D010455	Peptides
D000602	Amino Acids, Peptides, and Proteins
D009479	Neuropeptides

Browse Leaves

Not provided

Browse Branches

Not provided