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

NCT04532801 | Withdrawn Phase 1 DMC FDA Drug

• 1 other identifier: 267337
• Study Type: interventional
• Target: N/A
• Locations: 1 country
• Sites: 1

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.

Conditions

Insulin; Glucose; Healthy Volunteers; Women; Pregnancy

Keywords

kisspeptin; follicular phase

Outcome Measures

Primary Outcomes (1)

• Beta-cell responsivity index

  Average beta-cell responsivity index derived from mixed meal tolerance data comparing placebo and kisspeptin arms

  up to 6 months

Other Outcomes (1)

• Fasting insulin level

  up to 6 months

Study Arms (2)

kisspeptin-10

EXPERIMENTAL

kisspeptin infusion

Drug: Kisspeptin-10; Other: mixed meal tolerance test

placebo

PLACEBO COMPARATOR

placebo

Other: mixed meal tolerance test

Interventions

Kisspeptin-10 DRUG

kisspeptin-10 IV infusion

Also known as: kisspeptin

kisspeptin-10

mixed meal tolerance test OTHER

mixed meal tolerance test

kisspeptin-10; placebo

Eligibility Criteria

• Age: 18 Years - 40 Years
• Sex: female
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

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

Contact the study team to discuss eligibility requirements. They can help determine if this study is right for you.

Sponsors & Collaborators

• Stephanie B. Seminara, MD: lead

Study Sites (1)

Massachusetts General Hospital

Boston, Massachusetts, 02114, United States

Location

MeSH Terms

Conditions

Insulin Resistance

Interventions

KISS1 protein, human; Kisspeptins

Condition Hierarchy (Ancestors)

Hyperinsulinism; Glucose Metabolism Disorders; Metabolic Diseases; Nutritional and Metabolic Diseases

Intervention Hierarchy (Ancestors)

Intercellular Signaling Peptides and Proteins; Peptides; Amino Acids, Peptides, and Proteins; Neuropeptides; Tumor Suppressor Proteins; Neoplasm Proteins; Proteins

Study Officials

• Margaret Lippincott, MD

  Massachusetts General Hospital

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: OTHER
• Intervention Model: CROSSOVER
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: Chief, Reproductive Endocrine Unit; Professor of Medicine, Harvard Medical School; Director, Harvard Reproductive Endocrine Sciences Center

Model Details: physiologic studies

Study Record Dates

• First Submitted: August 23, 2020
• First Posted: August 31, 2020
• Study Start: September 1, 2019
• Primary Completion: August 31, 2024
• Study Completion: December 21, 2024
• Last Updated: August 1, 2024

Record last verified: 2024-07

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)