NCT01760772

Brief Summary

Individuals with obesity have an increased risk for heart disease and diabetes. There are current drugs on the market that target the hormone, Glucagon like peptide-1 (GLP-1) to treat diabetes. The investigators want to determine if targeting this hormone will also help people with high cholesterol and triglycerides. In this study, the investigators are looking at the role of GLP-1 in healthy subjects and subjects that have had bariatric surgery.

Trial Health

43
At Risk

Trial Health Score

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

Trial has exceeded expected completion date
Enrollment
42

participants targeted

Target at P25-P50 for not_applicable

Timeline
Completed

Started Feb 2013

Typical duration for not_applicable

Geographic Reach
1 country

1 active site

Status
unknown

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

November 17, 2012

Completed
2 months until next milestone

First Posted

Study publicly available on registry

January 4, 2013

Completed
28 days until next milestone

Study Start

First participant enrolled

February 1, 2013

Completed
2 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

February 1, 2015

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

February 1, 2015

Completed
Last Updated

January 4, 2013

Status Verified

November 1, 2012

Enrollment Period

2 years

First QC Date

November 17, 2012

Last Update Submit

January 2, 2013

Conditions

Heart Disease

Keywords

heart diseaseGLP-1Exendin-9postprandial lipids

Outcome Measures

Primary Outcomes (1)

  • Postprandial Lipids Levels and Apolipoprotein B (ApoB) Levels in plasma

    Total and lipoprotein-associated triglyceride and cholesterol levels in baseline and postprandial plasma. Total apolipoprotein B48 (ApoB48) and apolipoprotein B100 (ApoB100) levels in baseline and postprandial plasma.

    2 years

Secondary Outcomes (3)

  • Plasma insulin and glucagon

    2 years

  • Plasma free fatty acid (FFA) and glucose levels

    2 years

  • Plasma d-xylose and acetaminophen levels

    2 years

Study Arms (3)

Saline

PLACEBO COMPARATOR

0.9% saline

Other: saline

Exendin-9 (Ex-9)

EXPERIMENTAL

Bolus of Ex-9 (7,500 pmol/kg) followed by a continuous infusion at 750 pmol/kg/min

Drug: Exendin-9

GLP-1

EXPERIMENTAL

GLP-1 infusion at 0.3 pmol/kg/min

Drug: GLP-1

Interventions

Exendin-9DRUG

Bolus of Ex-9 (7500 pmol/kg) over 1 minute followed by continuous infusion at 750 pmol/kg/min

Also known as: Synthetic exendin (9-39) injection
Exendin-9 (Ex-9)
GLP-1DRUG

Constant infusion of GLP-1 at 0.3 pmol/kg/min

Also known as: 7-36 amide
GLP-1
salineOTHER

Constant infusion

Saline

Eligibility Criteria

Age40 Years - 60 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64)

You may qualify if:

  • Aim 1: Healthy, normolipemic men and postmenopausal women; aged 40-60 years; BMI between 25-35
  • Aim 2: Men and postmenopausal women after successful vertical sleeve gastrectomy (VSG) surgery and age- and weight-matched non-surgical control men and postmenopausal women; ages between 40-6- years; BMI between 28-35; steady weight for at least 3 months prior to study

You may not qualify if:

  • History or clinical evidence of impaired fasting glucose or diabetes mellitus, myocardial infarction or symptoms of congestive heart failure, history or active liver or renal disease, calculated glomerular filtration rate \< 60 mL/min).
  • History of extreme dyslipidemia (i.e. familial hypercholesterolemia) or Cardiovascular disease (CVD).
  • Fasting plasma total cholesterol \> 200 mg/dL and fasting plasma TGs \> 150 mg/dL.
  • Surgery within 6 months.
  • Pregnancy or lactation.
  • Anemia defined as hematocrit \< 33%.
  • History of cancer or anorexia nervosa or GI disorders.
  • Use of medications that alter insulin sensitivity (i.e. niacin, glucocorticoids, metformin) or lipid metabolism (i.e. statin, niacin, fibrate, ezetimibe).
  • Plasma HbA1c \> 6.0.
  • Fasting glucose \> 110 mg/dL
  • Electrocardiogram (ECG) abnormalities: evidence of ischemia or arrhythmia.
  • History of CVD.
  • Fasting plasma total cholesterol \> 250 mg/dL and fasting plasma TGs \> 300 mg/dL.
  • Surgical intervention within 6 months.
  • Anemia defined as hematocrit \< 33%.
  • +6 more criteria

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Veteran's Affairs Clinical Research Unit

Cincinnati, Ohio, 45220, United States

Location

MeSH Terms

Conditions

Heart Diseases

Interventions

exendin (9-39)InjectionsGlucagon-Like Peptide 1Sodium Chloride

Condition Hierarchy (Ancestors)

Cardiovascular Diseases

Intervention Hierarchy (Ancestors)

Drug Administration RoutesDrug TherapyTherapeuticsGlucagon-Like PeptidesProglucagonGastrointestinal HormonesHormonesHormones, Hormone Substitutes, and Hormone AntagonistsChloridesHydrochloric AcidChlorine CompoundsInorganic ChemicalsSodium Compounds

Study Officials

  • Michelle R Adams, PhD

    University of Cincinnati

    PRINCIPAL INVESTIGATOR

  • David D'Alessio, MD

    University of Cincinnati

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Michelle R Adams, PhD

CONTACT

513-558-6920michelle.adams@uc.edu

David D'Alessio, MD

CONTACT

513-558-6689DALESSD@UCMAIL.UC.EDU

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
PARTICIPANT
Purpose
BASIC SCIENCE
Intervention Model
FACTORIAL
Sponsor Type
OTHER
Responsible Party
SPONSOR INVESTIGATOR
PI Title
Professor

Study Record Dates

First Submitted

November 17, 2012

First Posted

January 4, 2013

Study Start

February 1, 2013

Primary Completion

February 1, 2015

Study Completion

February 1, 2015

Last Updated

January 4, 2013

Record last verified: 2012-11

Locations

US(1)