NCT02743598

Brief Summary

This study will test the effect of liraglutide on cognitive function in HIV-infected overweight or obese subjects with type 2 diabetes.

Trial Health

57
Monitor

Trial Health Score

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

Enrollment
4

participants targeted

Target at below P25 for phase_4

Timeline
Completed

Started Sep 2016

Geographic Reach
1 country

1 active site

Status
terminated

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

April 7, 2016

Completed
12 days until next milestone

First Posted

Study publicly available on registry

April 19, 2016

Completed
5 months until next milestone

Study Start

First participant enrolled

September 1, 2016

Completed
1.7 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 1, 2018

Completed
3 months until next milestone

Study Completion

Last participant's last visit for all outcomes

September 1, 2018

Completed
Last Updated

July 29, 2022

Status Verified

July 1, 2022

Enrollment Period

1.7 years

First QC Date

April 7, 2016

Last Update Submit

July 27, 2022

Conditions

HIV InfectionDiabetes Mellitus Type 2ObesityOverweightMetabolic Syndrome

Keywords

HIV infectionDiabetes Mellitus type 2ObesityNeurocognitive function

Outcome Measures

Primary Outcomes (2)

  • Neurocognitive performance- change in global cognitive scores on a standard neuropsychological profile

    6 months

  • Neurocognitive performance- change in domain averages on a standard neuropsychological profile

    6 months

Secondary Outcomes (16)

  • Change from baseline high sensitivity C-reactive protein

    3 and 6 months

  • Change from baseline d-dimer

    3 and 6 months

  • Change from baseline Interleukin 6

    3 and 6 months

  • Change from baseline plasma soluble cluster of differentiation 14 (CD14)

    3 and 6 months

  • Change from baseline BMI

    3 and 6 months

  • +11 more secondary outcomes

Study Arms (1)

Liraglutide

EXPERIMENTAL
Drug: Liraglutide

Interventions

LiraglutideDRUG
Liraglutide

Eligibility Criteria

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

You may qualify if:

  • HIV controlled on therapy for at least 12 weeks
  • Viral load \< 200 copies
  • BMI \>27 to 45
  • Diagnosis of DM type 2 with A1-C \>7 to 15
  • Participants must be willing to comply with all study related procedures

You may not qualify if:

  • Personal or family history of pancreatitis
  • Medullary thyroid carcinoma (MTC) or Multiple Endocrine Neoplasia Syndrome Type 2 (MEN 2)
  • Gastroparesis
  • Allergy to liraglutide or any of the active ingredients in liraglutide or other GLP-1 analogue
  • Weight loss drugs other than metformin
  • Type 1 diabetes mellitus or diabetic ketoacidosis
  • Known major cognitive deficit dementia, history of head trauma with loss of consciousness \>30 min, history of stroke, current central nervous system (CNS) disorder such as seizures or opportunistic CNS infection
  • Renal insufficiency defined as creatinine clearance \< 60 mL/min
  • Active opportunistic infections
  • Pregnancy or breastfeeding
  • Unstable cardiovascular disease with hospitalization within 1 year for acute coronary syndrome
  • Decompensated heart failure
  • Substance abuse
  • Active alcohol or opioid substitution therapy
  • Serious or unstable medical or psychological conditions that would compromise the subject's safety for successful participation

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Cherie Vaz

Philadelphia, Pennsylvania, 19140, United States

Location

MeSH Terms

Conditions

HIV InfectionsDiabetes Mellitus, Type 2ObesityOverweightMetabolic Syndrome

Interventions

Liraglutide

Condition Hierarchy (Ancestors)

Blood-Borne InfectionsCommunicable DiseasesInfectionsSexually Transmitted Diseases, ViralSexually Transmitted DiseasesLentivirus InfectionsRetroviridae InfectionsRNA Virus InfectionsVirus DiseasesGenital DiseasesUrogenital DiseasesImmunologic Deficiency SyndromesImmune System DiseasesDiabetes MellitusGlucose Metabolism DisordersMetabolic DiseasesNutritional and Metabolic DiseasesEndocrine System DiseasesOvernutritionNutrition DisordersBody WeightSigns and SymptomsPathological Conditions, Signs and SymptomsInsulin ResistanceHyperinsulinism

Intervention Hierarchy (Ancestors)

Glucagon-Like Peptide 1Glucagon-Like PeptidesProglucagonGastrointestinal HormonesHormonesHormones, Hormone Substitutes, and Hormone Antagonists

Study Officials

  • Cherie Vaz, MD Dipl ABOM

    Temple University

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
phase 4
Allocation
NA
Masking
NONE
Purpose
TREATMENT
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

April 7, 2016

First Posted

April 19, 2016

Study Start

September 1, 2016

Primary Completion

June 1, 2018

Study Completion

September 1, 2018

Last Updated

July 29, 2022

Record last verified: 2022-07

Data Sharing

IPD Sharing
Will not share

Locations

US(1)