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Trial record 30 of 748 for:    Area Under Curve AND meal

Kisspeptin Influence on Glucose Homeostasis

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ClinicalTrials.gov Identifier: NCT02953834
Recruitment Status : Recruiting
First Posted : November 3, 2016
Last Update Posted : July 24, 2019
Sponsor:
Information provided by (Responsible Party):
Stephanie B. Seminara, MD, Massachusetts General Hospital

Brief Summary:
This study examines how a naturally occurring peptide called kisspeptin might regulate blood sugar and insulin levels.

Condition or disease Intervention/treatment Phase
Impaired Glucose Tolerance Hypogonadism Drug: kisspeptin 112-121 Other: Insulin Resistance Test Other: Placebo Phase 1

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 413 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary Purpose: Other
Official Title: Kisspeptin Influence on Glucose Homeostasis
Actual Study Start Date : June 6, 2017
Estimated Primary Completion Date : December 2022
Estimated Study Completion Date : December 2023

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Experimental: Kisspeptin and Insulin Resistance Test
intravenous administration of kisspeptin 112-121; eat a standard mixed meal or drink a standard mixed meal or 75 grams of oral glucose
Drug: kisspeptin 112-121
Dose: 0.313-12.5 mcg/kg Duration: up to 16 hours

Other: Insulin Resistance Test
Eat or drink a standard meal OR drink a standard drink containing 75 grams of sugar

Placebo Comparator: Placebo and Insulin Resistance Test
intravenous administration of IV fluids that contain no study drug; eat a standard mixed meal or drink a standard mixed meal or 75 grams of oral glucose
Other: Insulin Resistance Test
Eat or drink a standard meal OR drink a standard drink containing 75 grams of sugar

Other: Placebo
Receive intravenous fluids for up to 16 hours that do not contain any study drug




Primary Outcome Measures :
  1. Average difference in area under the curve of insulin in response to a mixed meal tolerance test [ Time Frame: 4 hours ]
    Compares difference on and off kisspeptin


Secondary Outcome Measures :
  1. Average difference in area under the curve of glucose in response to a mixed meal tolerance test [ Time Frame: 4 hours ]
    Compares difference on and off kisspeptin

  2. Average difference in area under the curve of glucagon-like peptide 1 in response to a mixed meal tolerance test [ Time Frame: 4 hours ]
    Compares difference on and off kisspeptin



Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 60 Years   (Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion/Exclusion Criteria:

History:

  • stable weight for previous three months (Body Mass Index less than 25),
  • no active illicit drug use,
  • no history of a medication reaction requiring emergency medical care,
  • no difficulty with blood draws.

Physical examination:

• systolic BP < 140 mm Hg, diastolic < 90 mm Hg,

Laboratory studies: (per MGH reference ranges)

  • normal hemoglobin, unless hypogonadal then no lower than 0.5 gm/dL below the lower limit of the reference range for normal women (as men and women with hypogonadism have lower hemoglobin levels off of treatment)
  • hemoglobin A1C < 6.5%
  • BUN, creatinine not elevated
  • AST, ALT < 3x upper limit of normal
  • negative serum pregnancy test (for all women)

Additional Criteria by Study Population

Healthy Women:

  • no history of chronic disease, except well controlled thyroid disease,
  • no history of diabetes in a first degree relative,
  • no use of contraceptive pills, patches or vaginal rings within last 4 weeks.

Men and Women with Impaired Glucose Tolerance (IGT):

  • diagnosis of impaired glucose tolerance by oral glucose tolerance test,
  • all medical conditions well-controlled.

Men and Women with Hypogonadism

  • diagnosis of hypogonadism,
  • all other medical conditions well-controlled,
  • if applicable, able to undergo appropriate washout from hormone therapy.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02953834


Contacts
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Contact: Margaret Lippincott, MD 617-726-8434 mlippincott@partners.org

Locations
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United States, Massachusetts
Massachusetts General Hospital Recruiting
Boston, Massachusetts, United States, 02114
Contact: Margaret Lippincott, MD    617-726-8434    mlippincott@partners.org   
Principal Investigator: Margaret Lippincott, MD         
Sub-Investigator: Stephanie Seminara, MD         
Sponsors and Collaborators
Stephanie B. Seminara, MD
Investigators
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Principal Investigator: Margaret Lippincott, MD Massachusetts General Hospital

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Responsible Party: Stephanie B. Seminara, MD, Chief, Reproductive Endocrine Unit; Professor of Medicine, Harvard Medical School; Co-Director, Harvard Reproductive Endocrine Sciences Center, Massachusetts General Hospital
ClinicalTrials.gov Identifier: NCT02953834     History of Changes
Other Study ID Numbers: 2016P001769
First Posted: November 3, 2016    Key Record Dates
Last Update Posted: July 24, 2019
Last Verified: July 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Yes
Plan Description: After primary results are published, the authors will provide individuals participant data upon request as long as it does not conflict with state or Institutional regulations.

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Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Stephanie B. Seminara, MD, Massachusetts General Hospital:
insulin regulation in pregnancy
kisspeptin
Additional relevant MeSH terms:
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Glucose Intolerance
Hypogonadism
Gonadal Disorders
Endocrine System Diseases
Hyperglycemia
Glucose Metabolism Disorders
Metabolic Diseases
Insulin
Insulin, Globin Zinc
Hypoglycemic Agents
Physiological Effects of Drugs