NCT02023918

Brief Summary

Growth hormone is well known to cause changes in glucose regulation. People with Laron syndrome are born without the growth hormone receptor and are protected from diabetes. Mice who are engineered without the growth hormone receptor are similarly protected from diabetes. Conversely, people who have excessive amounts of growth hormone, such as patients with acromegaly, have an increased risk for type 2 diabetes. In acromegaly patients, treatment with pegvisomant, a medication that reduces insulin like growth factor-1 by blocking the growth hormone receptor, significantly improves insulin resistance. Pegvisomant has not been explored as a possibility for the treatment of type 2 diabetes or insulin resistance in people without acromegaly. In this study, the investigators hope to study the metabolic effects of pegvisomant on people who have insulin resistance but not diabetes. Pegivosmant is expected to improve insulin resistance in the liver, fat and muscle as well as decrease serum free fatty acids.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
6

participants targeted

Target at below P25 for phase_2 diabetes

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

First Submitted

Initial submission to the registry

December 24, 2013

Completed
6 days until next milestone

First Posted

Study publicly available on registry

December 30, 2013

Completed
2 days until next milestone

Study Start

First participant enrolled

January 1, 2014

Completed
1.6 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

August 1, 2015

Completed
4 months until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2015

Completed
1.3 years until next milestone

Results Posted

Study results publicly available

March 13, 2017

Completed
Last Updated

April 24, 2017

Status Verified

April 1, 2017

Enrollment Period

1.6 years

First QC Date

December 24, 2013

Results QC Date

November 9, 2016

Last Update Submit

April 20, 2017

Conditions

DiabetesMetabolic SyndromeInsulin Resistance

Keywords

Growth hormone antagonism

Outcome Measures

Primary Outcomes (1)

  • Insulin Sensitivity

    Investigators will measure insulin sensitivity via hyperinsulinemic euglycemic clamp prior to the initiation of the study medication and then again at the end of the 28 days to evaluate the effect of pegvisomant on insulin sensitivity and reported as HOMA-IR. HOMA-IR was derived from fasting insulin and fasting glucose by the calculation: fasting insulin (microU/L) x fasting glucose (nmol/L)/22.5

    28 days

Secondary Outcomes (1)

  • Lipolysis

    28 days

Study Arms (1)

Pegvisomant arm

EXPERIMENTAL

Pegvisomant 20 mg subcutaneously Qday x 28 days will be administered by the study subject.

Drug: pegvisomant

Interventions

pegvisomantDRUG

Pegvisomant 20 mg subcutaneously Qday will be administered by the study subject for 28 days during this study.

Also known as: Somavert
Pegvisomant arm

Eligibility Criteria

Age18 Years - 80 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • BMI between 18-35
  • Homeostatic model assessment - insulin resistance (HOMA-IR) \>2.77
  • Able to administer daily subcutaneous injections of pegvisomant

You may not qualify if:

  • Pregnancy
  • Breastfeeding in the last 6 months
  • Liver function tests greater than 3x the upper limits of normal
  • unstable diet over the last 3 months
  • unstable weight over the last 6 months
  • unstable lipid lowering regimen
  • diabetes - type 1 or type 2
  • History of major gastrointestinal surgery
  • History of pancreatic, liver, biliary, or intestinal disease
  • Fasting blood glucose \>126
  • Fasting triglycerides\>500
  • A1c\>6.5

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

San Francisco General Hospital

San Francisco, California, 94110, United States

Location

MeSH Terms

Conditions

Diabetes MellitusMetabolic SyndromeInsulin Resistance

Interventions

pegvisomant

Condition Hierarchy (Ancestors)

Glucose Metabolism DisordersMetabolic DiseasesNutritional and Metabolic DiseasesEndocrine System DiseasesHyperinsulinism

Results Point of Contact

Title
Dr. Ethan Weiss
Organization
UCSF
ethan.weiss@ucsf.edu
4155140819

Study Officials

  • Ethan J Weiss, MD

    University of California, San Francisco

    PRINCIPAL INVESTIGATOR

  • Morris Schambelan, MD

    University of California, San Francisco

    PRINCIPAL INVESTIGATOR

  • Kathleen Mulligan, PhD

    University of California, San Francisco

    PRINCIPAL INVESTIGATOR

Publication Agreements

PI is Sponsor Employee
No
Restrictive Agreement
No

Study Design

Study Type
interventional
Phase
phase 2
Allocation
NA
Masking
NONE
Purpose
TREATMENT
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

December 24, 2013

First Posted

December 30, 2013

Study Start

January 1, 2014

Primary Completion

August 1, 2015

Study Completion

December 1, 2015

Last Updated

April 24, 2017

Results First Posted

March 13, 2017

Record last verified: 2017-04

Locations

US(1)