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Assessing the Impact of INSTI to PI Switch on Insulin Sensitivity and Fat Metabolism (ADIPOSITY)

Primary Purpose

HIV I Infection, Adiposity

Status

Completed

Phase

Not Applicable

Locations

United States

Study Type

Interventional

Intervention

Frequently sampled glucose tolerance testing

abdominal subcutaneous adipose tissue biopsy

MRI scan to assess intrahepatic triglyceride content

About this trial

This is an interventional diagnostic trial for HIV I Infection

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

• Must be enrolled in the DEFINE study TMC114FD2HTX4004
- Must sign an ICF indicating that they understand the purpose of, and procedures required for, the study and are willing to participate in the study.

Exclusion Criteria:

• Contraindication to magnetic resonance imaging as determined by institutional policy.
- Current diagnosis of diabetes mellitus

Sites / Locations

Washington University School of Medicine

Arms of the Study

Arm 1

Arm 2

Arm Type

Active Comparator

Arm Label

Immediate switch

Delayed switch

Arm Description

Immediate switch

Delayed switch

Outcomes

Primary Outcome Measures

Insulin Sensitivity measured by homeostatic model assessment for insulin resistance {HOMA_IR}

Change in insulin sensitivity (SI) at 12 weeks assessed by using a 3-hour frequently sampled oral glucose tolerance testing (fsOGTT).to calculate HOMA_IR

Secondary Outcome Measures

Intrahepatic triglyceride (IHTG) content measure by magnetic resonance

Change in intrahepatic triglyceride (IHTG) content measured by magnetic resonance imaging (MRI

Intrahepatic triglyceride (IHTG) content measure by magnetic resonance

Change in intrahepatic triglyceride (IHTG) content measured by magnetic resonance imaging (MRI

Adipocyte size measured by osmium tetroxide fixation technique

Change in adipocyte size by the osmium tetroxide fixation technique

Adipocyte size measured by osmium tetroxide fixation technique

Change in adipocyte size by the osmium tetroxide fixation technique

Adipocyte gene expression correlated with adipose tissue development

Change in expression of adipose tissue genes correlated with adipose tissue development, lipogenesis, inflammation and endocrine function measured by RNA sequencing

Adipocyte gene expression correlated with adipose tissue development

Change in expression of adipose tissue genes correlated with adipose tissue development, lipogenesis, inflammation and endocrine function measured by RNA sequencing

Insulin Sensitivity measured by homeostatic model assessment for insulin resistance {HOMA_IR}

Change in insulin sensitivity (SI) at 12 weeks assessed by using a 3-hour frequently sampled oral glucose tolerance testing (fsOGTT).to calculate HOMA_IR

Full Information

NCT ID

NCT04675255

First Posted

October 13, 2020

Last Updated

August 1, 2023

Sponsor

Washington University School of Medicine

Collaborators

Janssen Scientific Affairs, LLC

1. Study Identification

Unique Protocol Identification Number

NCT04675255

Brief Title

Assessing the Impact of INSTI to PI Switch on Insulin Sensitivity and Fat Metabolism

Acronym

ADIPOSITY

Official Title

WU 360: Assessing the Impact of Integrase Strand Transfer Inhibitors (INSTI) to Protease Inhibitor (PI) Switch on Insulin Sensitivity and Fat Metabolism (ADIPOSITY): a Sub-study of DEFINE

Study Type

Interventional

2. Study Status

Record Verification Date

August 2023

Overall Recruitment Status

Completed

Study Start Date

January 1, 2021 (Actual)

Primary Completion Date

June 8, 2023 (Actual)

Study Completion Date

June 8, 2023 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Sponsor

Name of the Sponsor

Washington University School of Medicine

Collaborators

Janssen Scientific Affairs, LLC

4. Oversight

Studies a U.S. FDA-regulated Drug Product

Studies a U.S. FDA-regulated Device Product

Data Monitoring Committee

5. Study Description

Brief Summary

A substudy of TMC114FD2HTX4004 that will perform glucose tolerance testing, adipose testing and MRI scan at baseline, 12 and 24 weeks post switch of ART medications.

Detailed Description

Synopsis Full study title: Assessing the impact of integrase strand transfer inhibitors (INSTI) to protease inhibitor (PI) switch on insulin sensitivity and fat metabolism (ADIPOSITY): a sub-study of DEFINE Endpoints and objectives: The following endpoints will be determined 12 and 24 weeks after switch from an INSTI-based antiretroviral therapy (ART) regimen to a PI-based regimen: Primary endpoint: Change in insulin sensitivity (SI) at 12 weeks assessed by using a 3-hour frequently sampled oral glucose tolerance testing (fsOGTT). Secondary endpoints: 1) Change in insulin sensitivity (SI) at 24 weeks assessed by using a 3-hour frequently sampled oral glucose tolerance testing (fsOGTT); 2) Change in insulin secretion during the fsOGTT assessed by using C-peptide deconvolution; 3) Change in intrahepatic triglyceride (IHTG) content measured by magnetic resonance imaging (MRI); 4) Change in adipocyte size by the osmium tetroxide fixation technique; and 5) Change in expression of genes associated with adipose tissue development, lipogenesis, inflammation and endocrine function by RNA sequencing. Hypothesis: Insulin sensitivity will improve following switch from INSTIs to PIs

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

HIV I Infection, Adiposity

7. Study Design

Primary Purpose

Diagnostic

Study Phase

Not Applicable

Interventional Study Model

Parallel Assignment

Masking

None (Open Label)

Allocation

Randomized

Enrollment

8 (Actual)

8. Arms, Groups, and Interventions

Arm Title

Immediate switch

Arm Type

Active Comparator

Arm Description

Immediate switch

Arm Title

Delayed switch

Arm Type

Active Comparator

Arm Description

Delayed switch

Intervention Type

Procedure

Intervention Name(s)

Frequently sampled glucose tolerance testing

Intervention Description

Frequently sampled glucose tolerance testing

Intervention Type

Procedure

Intervention Name(s)

abdominal subcutaneous adipose tissue biopsy

Intervention Description

abdominal subcutaneous adipose tissue biopsy

Intervention Type

Procedure

Intervention Name(s)

MRI scan to assess intrahepatic triglyceride content

Intervention Description

MRI scan to assess intrahepatic triglyceride content

Primary Outcome Measure Information:

Title

Insulin Sensitivity measured by homeostatic model assessment for insulin resistance {HOMA_IR}

Description

Change in insulin sensitivity (SI) at 12 weeks assessed by using a 3-hour frequently sampled oral glucose tolerance testing (fsOGTT).to calculate HOMA_IR

Time Frame

12 weeks

Secondary Outcome Measure Information:

Title

Intrahepatic triglyceride (IHTG) content measure by magnetic resonance

Description

Change in intrahepatic triglyceride (IHTG) content measured by magnetic resonance imaging (MRI

Time Frame

12 weeks

Title

Intrahepatic triglyceride (IHTG) content measure by magnetic resonance

Description

Change in intrahepatic triglyceride (IHTG) content measured by magnetic resonance imaging (MRI

Time Frame

24 weeks

Title

Adipocyte size measured by osmium tetroxide fixation technique

Description

Change in adipocyte size by the osmium tetroxide fixation technique

Time Frame

12 weeks

Title

Adipocyte size measured by osmium tetroxide fixation technique

Description

Change in adipocyte size by the osmium tetroxide fixation technique

Time Frame

24 weeks

Title

Adipocyte gene expression correlated with adipose tissue development

Description

Change in expression of adipose tissue genes correlated with adipose tissue development, lipogenesis, inflammation and endocrine function measured by RNA sequencing

Time Frame

12 weeks

Title

Adipocyte gene expression correlated with adipose tissue development

Description

Change in expression of adipose tissue genes correlated with adipose tissue development, lipogenesis, inflammation and endocrine function measured by RNA sequencing

Time Frame

24 weeks

Title

Insulin Sensitivity measured by homeostatic model assessment for insulin resistance {HOMA_IR}

Description

Change in insulin sensitivity (SI) at 12 weeks assessed by using a 3-hour frequently sampled oral glucose tolerance testing (fsOGTT).to calculate HOMA_IR

Time Frame

24 weeks

10. Eligibility

Sex

All

Minimum Age & Unit of Time

18 Years

Accepts Healthy Volunteers

Eligibility Criteria

Inclusion Criteria: • Must be enrolled in the DEFINE study TMC114FD2HTX4004 Must sign an ICF indicating that they understand the purpose of, and procedures required for, the study and are willing to participate in the study. Exclusion Criteria: • Contraindication to magnetic resonance imaging as determined by institutional policy. Current diagnosis of diabetes mellitus

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

Jane O'Halloran, MB BA PhD

Organizational Affiliation

Washington University School of Medicine in St. Louis

Official's Role

Principal Investigator

Facility Information:

Facility Name

Washington University School of Medicine

City

Saint Louis

State/Province

Missouri

ZIP/Postal Code

63110

Country

United States

12. IPD Sharing Statement

Plan to Share IPD

IPD Sharing Plan Description

There is no plan

Learn more about this trial

Assessing the Impact of INSTI to PI Switch on Insulin Sensitivity and Fat Metabolism

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