HIV I InfectionADIPOSITYNCT04675255
Assessing the Impact of INSTI to PI Switch on Insulin Sensitivity and Fat Metabolism
A study testing Frequently sampled glucose tolerance testing, abdominal subcutaneous adipose tissue biopsy and MRI scan to assess intrahepatic triglyceride content in people with HIV I Infection and Adiposity, run by Washington University School of Medicine at 1 site in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- HIV I Infection, Adiposity
- What is being tested?
- Frequently sampled glucose tolerance testing, abdominal subcutaneous adipose tissue biopsy and MRI scan to assess intrahepatic triglyceride content
- Type of treatment
- Injection or infusion, Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 8 participants
- Where
- 1 siteUnited States
- Study dates
- 1 Jan 2021to 8 Jun 2023
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- • 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.
Who cannot join
- • Contraindication to magnetic resonance imaging as determined by institutional policy.
- Current diagnosis of diabetes mellitus
Trial locations and contacts
1 site in 1 country.
United States1 site
Washington University School of Medicine
St Louis, Missouri, 63110
About this study
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
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.
Read the 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
- Conditions
- HIV I Infection, Adiposity
- Being tested
- Frequently sampled glucose tolerance testing, abdominal subcutaneous adipose tissue biopsy, MRI scan to assess intrahepatic triglyceride content
- Medical subject headings
- Obesity
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Frequently sampled glucose tolerance testingProcedure or surgery
Frequently sampled glucose tolerance testing
abdominal subcutaneous adipose tissue biopsyProcedure or surgery
abdominal subcutaneous adipose tissue biopsy
MRI scan to assess intrahepatic triglyceride contentProcedure or surgery
MRI scan to assess intrahepatic triglyceride content
| Study group | Role | What they receive |
|---|---|---|
| Immediate switch | Active comparator | Immediate switch Receives: Procedure: Frequently sampled glucose tolerance testing; Procedure: abdominal subcutaneous adipose tissue biopsy; Procedure: MRI scan to assess intrahepatic triglyceride content |
| Delayed switch | Active comparator | Delayed switch Receives: Procedure: Frequently sampled glucose tolerance testing; Procedure: abdominal subcutaneous adipose tissue biopsy; Procedure: MRI scan to assess intrahepatic triglyceride content |
What is being measured
The primary outcome is the main question the study is designed to answer.
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
Measured: 12 weeks
Secondary outcomes (7)
Intrahepatic triglyceride (IHTG) content measure by magnetic resonance
Change in intrahepatic triglyceride (IHTG) content measured by magnetic resonance imaging (MRI
Measured: 12 weeks
Intrahepatic triglyceride (IHTG) content measure by magnetic resonance
Change in intrahepatic triglyceride (IHTG) content measured by magnetic resonance imaging (MRI
Measured: 24 weeks
Adipocyte size measured by osmium tetroxide fixation technique
Change in adipocyte size by the osmium tetroxide fixation technique
Measured: 12 weeks
Adipocyte size measured by osmium tetroxide fixation technique
Change in adipocyte size by the osmium tetroxide fixation technique
Measured: 24 weeks
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
Measured: 12 weeks
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
Measured: 24 weeks
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
Measured: 24 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted19 Dec 2020
- Study start1 Jan 2021
- Primary completion8 Jun 2023
- Study completion8 Jun 2023
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for HIV I InfectionStudies of the same condition, open and under way.
- More trials run by Washington University School of MedicineThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Diagnosis
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 8 participants (actual)
Sponsor and investigators
- Lead sponsor
- Washington University School of Medicine
- Sponsor type
- University, hospital or other
- Collaborators
- Janssen Scientific Affairs, LLC
- Responsible party
- Sponsor
- Investigators
- Jane O'Halloran, MB BA PhD, Principal investigator, Washington University School of Medicine in St. Louis
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04675255
- Sponsor's protocol ID
- 202008043
- Acronym
- ADIPOSITY
- Status last verified
- Aug 2023
- First submitted
- 13 Oct 2020
- Last updated
- 3 Aug 2023
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: There is no plan
Study at a glance
From the registry record, last updated by the sponsor on 3 Aug 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT04675255
- Acronym / sponsor ID
- ADIPOSITY / 202008043
- Conditions
- HIV I Infection, Adiposity
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 8 participants (actual)
- Lead sponsor
- Washington University School of MedicineUniversity, hospital or other
- Collaborators
- Janssen Scientific Affairs, LLC
- Study start
- 1 Jan 2021 (actual)
- Primary completion
- 8 Jun 2023 (actual)
- Study completion
- 8 Jun 2023 (actual)
- First posted
- 19 Dec 2020 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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
Study design
- Primary purpose
- Diagnosis
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Immediate switch | Active comparator | Procedure: Frequently sampled glucose tolerance testing, Procedure: abdominal subcutaneous adipose tissue biopsy, Procedure: MRI scan to assess intrahepatic triglyceride contentImmediate switch |
| Delayed switch | Active comparator | Procedure: Frequently sampled glucose tolerance testing, Procedure: abdominal subcutaneous adipose tissue biopsy, Procedure: MRI scan to assess intrahepatic triglyceride contentDelayed switch |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- • Must be enrolled in the DEFINE study TMC114FD2HTX4004
Key exclusion criteria (2 listed)
- • Contraindication to magnetic resonance imaging as determined by institutional policy.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Frequently sampled glucose tolerance testingFrequently sampled glucose tolerance testing | Procedure or surgery | Delayed switch, Immediate switch |
| abdominal subcutaneous adipose tissue biopsyabdominal subcutaneous adipose tissue biopsy | Procedure or surgery | Delayed switch, Immediate switch |
| MRI scan to assess intrahepatic triglyceride contentMRI scan to assess intrahepatic triglyceride content | Procedure or surgery | Delayed switch, Immediate switch |
Primary outcome
Insulin Sensitivity measured by homeostatic model assessment for insulin resistance {HOMA_IR}
Time frame: 12 weeks
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
7 secondary outcomes
Intrahepatic triglyceride (IHTG) content measure by magnetic resonance
Time frame: 12 weeks
Intrahepatic triglyceride (IHTG) content measure by magnetic resonance
Time frame: 24 weeks
Adipocyte size measured by osmium tetroxide fixation technique
Time frame: 12 weeks
Adipocyte size measured by osmium tetroxide fixation technique
Time frame: 24 weeks
Adipocyte gene expression correlated with adipose tissue development
Time frame: 12 weeks
Adipocyte gene expression correlated with adipose tissue development
Time frame: 24 weeks
Insulin Sensitivity measured by homeostatic model assessment for insulin resistance {HOMA_IR}
Time frame: 24 weeks
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 3 Aug 2023.
- Individual participant dataSharing planned: No. There is no plan
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Jane O'Halloran, MB BA PhD principal investigator
Washington University School of Medicine in St. Louis
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Frequently sampled glucose tolerance testing, abdominal subcutaneous adipose tissue biopsy and MRI scan to assess intrahepatic triglyceride content in people with HIV I Infection and Adiposity, run by Washington University School of Medicine at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 3 Aug 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Insulin Sensitivity measured by homeostatic model assessment for insulin resistance {HOMA_IR} (time frame: 12 weeks). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 3 Aug 2023.