HAART-induced Lipodystrophy and Metabolic SyndromePhase 2NCT00140244
Randomized, Placebo-Controlled Study of Leptin for the Treatment of HIV Lipodystrophy and Metabolic Syndrome
A Phase 2 study testing r-metHuLeptin in people with HAART-induced Lipodystrophy and Metabolic Syndrome, run by Beth Israel Deaconess Medical Center at 1 site in United States.
Trial summary
The purpose of this study is to examine whether replacing leptin to normal levels can reverse the changes in fat distribution, lipid profile, and other metabolic problems associated with highly active antiretroviral therapy (HAART)-induced lipodystrophy and metabolic syndrome in HIV patients. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- HAART-induced Lipodystrophy and Metabolic Syndrome
- What is being tested?
- r-metHuLeptin
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 7 participants
- Where
- 1 siteUnited States
- Study dates
- Dec 2001to Jun 2011
- Phase
- Phase 2
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
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
- At least 18 years old
- Documented HIV infection
- Exposed to at least 6 months of cumulative highly active antiretroviral medications for HIV
- Developed fat depletion after starting HIV medications
- Low leptin level in the blood
- Fasting triglyceride level > 300 mg/dl
Who cannot join
- Active infectious diseases, except HIV
- Diabetes prior to starting HIV medications
- Alcohol or drug abuse
- Triglyceride level > 1000 mg/dl
- Significant kidney, liver, or thyroid dysfunction
- Cancer or lymphoma
- Pregnancy or planning to become pregnant during the study
Trial locations and contacts
1 site in 1 country.
United States1 site
Beth Israel Deaconess Medical Center
Boston, Massachusetts, 02215
About this study
Official title: Role of Leptin in Highly Active Antiretroviral Therapy (HAART)-Induced Lipodystrophy and Metabolic Syndrome in HAART-Treated HIV Patients
The purpose of this study is to examine whether replacing leptin to normal levels can reverse the changes in fat distribution, lipid profile, and other metabolic problems associated with highly active antiretroviral therapy (HAART)-induced lipodystrophy and metabolic syndrome in HIV patients.
Read the detailed description
Exposure to HIV medications has been associated with metabolic changes including generalized fat depletion (lipoatrophy), high triglyceride levels, and in some patients, high sugar levels or diabetes. This syndrome is associated with a deficiency of leptin, a hormone produced by fat cells. Recent studies involving leptin administration to patients with congenital lipoatrophy have shown dramatic improvements in metabolic parameters such as insulin resistance and hyperlipidemia. Leptin administration to patients with HAART-induced lipoatrophy may also lead to significant improvements in the metabolic abnormalities found in these HIV+ patients. The aims of this study are to examine the effect of leptin administration on insulin resistance and other parameters of the metabolic syndrome in HIV patients with HAART-induced lipoatrophy.
Comparison: Leptin-treated group to placebo-treated group
- Being tested
- r-metHuLeptin, Placebo
- Keywords
- leptin, lipodystrophy, insulin resistance, hyperlipidemia, metabolic syndrome
- Medical subject headings
- Metabolic Syndrome, Lipodystrophy, Insulin Resistance, Hyperlipidemias
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
r-metHuLeptinDrug
PlaceboDrug
| Study group | Role | What they receive |
|---|---|---|
| r-MetHuLeptin | Active comparator | r-MetHuLeptin SubQ once daily Receives: Drug: r-metHuLeptin |
| Placebo | Placebo comparator | SubQ once daily Receives: Drug: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
Serum Lipid Levels
Measured: At the end of each two month intervention
Secondary outcomes (12)
Insulin Resistance (as Assessed by HOMA-IR)
Measured: At the end of each two month intervention
Glycemia (as Assessed by Fasting Glucose)
Measured: At the end of each two month intervention
Low Density Lipoprotein (LDL) Cholesterol Levels
Measured: At the end of each two month intervention
Free Fatty Acid (FFA) Levels
Measured: At the end of each two month intervention
Blood Pressure
percent change in mean blood pressure
Measured: At the end of each two month intervention
Fibrinogen
Fibrinogen
Measured: At the end of each two month intervention
Insulin Levels
Measured: At the end of each two month intervention
Lean Body Mass
lean body mass
Measured: At the end of each two month intervention
Viral Load
Measured: At the end of each two month intervention
CD4+ Lymphocytes
Measured: At the end of each two month intervention
Interleukin-6 (IL-6) Levels
Measured: At the end of each two month intervention
Hepatic Fat Content
Measured: At the end of each two month intervention
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted1 Sep 2005 (estimated)
- Study startDec 2001
- Primary completionJun 2011
- Study completionJun 2011
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for HAART-induced Lipodystrophy and Metabolic SyndromeStudies of the same condition, open and under way.
- More trials run by Beth Israel Deaconess Medical CenterThe 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 2
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Triple blind
- Who is masked
- Participant, Care provider, Investigator
- Enrolment
- 7 participants (actual)
Sponsor and investigators
- Lead sponsor
- Beth Israel Deaconess Medical Center
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Christos Mantzoros, Beth Israel Deaconess Medical Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00140244
- Sponsor's protocol ID
- 2001P000484
- Other IDs
- R01DK058785
- Status last verified
- Apr 2017
- First submitted
- 30 Aug 2005
- Last updated
- 11 May 2017
- Results posted
- Yes, on ClinicalTrials.gov
Publications
Bouzoni E, Perakakis N, Connelly MA, Angelidi AM, Pilitsi E, Farr O, Stefanakis K, Mantzoros CS. PCSK9 and ANGPTL3 levels correlate with hyperlipidemia in HIV-lipoatrophy, are regulated by fasting and are not affected by leptin administered in physiologic or pharmacologic doses. Metabolism. 2022 Sep;134:155265. doi: 10.1016/j.metabol.2022.155265. Epub 2022 Jul 9.
PubMed 35820631Magkos F, Brennan A, Sweeney L, Kang ES, Doweiko J, Karchmer AW, Mantzoros CS. Leptin replacement improves postprandial glycemia and insulin sensitivity in human immunodeficiency virus-infected lipoatrophic men treated with pioglitazone: a pilot study. Metabolism. 2011 Jul;60(7):1045-9. doi: 10.1016/j.metabol.2010.10.002. Epub 2010 Nov 16.
PubMed 21081243
Study at a glance
From the registry record, last updated by the sponsor on 11 May 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Role of Leptin in Highly Active Antiretroviral Therapy (HAART)-Induced Lipodystrophy and Metabolic Syndrome in HAART-Treated HIV Patients
- ClinicalTrials.gov ID
- NCT00140244
- Acronym / sponsor ID
- 2001P000484
- Keywords
- leptin, lipodystrophy, insulin resistance, hyperlipidemia, metabolic syndrome
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 7 participants (actual)
- Lead sponsor
- Beth Israel Deaconess Medical CenterUniversity, hospital or other
- Collaborators
- National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK), Amgen
- Study start
- Dec 2001
- Primary completion
- Jun 2011 (actual)
- Study completion
- Jun 2011 (actual)
- First posted
- 1 Sep 2005 (estimated)
- Results
- Posted 6 Apr 2017
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The purpose of this study is to examine whether replacing leptin to normal levels can reverse the changes in fat distribution, lipid profile, and other metabolic problems associated with highly active antiretroviral therapy (HAART)-induced lipodystrophy and metabolic syndrome in HIV patients.
Detailed description
Exposure to HIV medications has been associated with metabolic changes including generalized fat depletion (lipoatrophy), high triglyceride levels, and in some patients, high sugar levels or diabetes. This syndrome is associated with a deficiency of leptin, a hormone produced by fat cells. Recent studies involving leptin administration to patients with congenital lipoatrophy have shown dramatic improvements in metabolic parameters such as insulin resistance and hyperlipidemia. Leptin administration to patients with HAART-induced lipoatrophy may also lead to significant improvements in the metabolic abnormalities found in these HIV+ patients. The aims of this study are to examine the effect of leptin administration on insulin resistance and other parameters of the metabolic syndrome in HIV patients with HAART-induced lipoatrophy.
Comparison: Leptin-treated group to placebo-treated group
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Triple blind (participant, care provider, investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| r-MetHuLeptin | Active comparator | Drug: r-metHuLeptinr-MetHuLeptin SubQ once daily |
| Placebo | Placebo comparator | Drug: PlaceboSubQ once daily |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- At least 18 years old
- Documented HIV infection
- Exposed to at least 6 months of cumulative highly active antiretroviral medications for HIV
- Developed fat depletion after starting HIV medications
- Low leptin level in the blood
Key exclusion criteria (7 listed)
- Active infectious diseases, except HIV
- Diabetes prior to starting HIV medications
- Alcohol or drug abuse
- Triglyceride level > 1000 mg/dl
- Significant kidney, liver, or thyroid dysfunction
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 |
|---|---|---|
| r-metHuLeptin | Drug | r-MetHuLeptin |
| Placebo | Drug | Placebo |
Primary outcome
Serum Lipid Levels
Time frame: At the end of each two month intervention
12 secondary outcomes
Insulin Resistance (as Assessed by HOMA-IR)
Time frame: At the end of each two month intervention
Glycemia (as Assessed by Fasting Glucose)
Time frame: At the end of each two month intervention
Low Density Lipoprotein (LDL) Cholesterol Levels
Time frame: At the end of each two month intervention
Free Fatty Acid (FFA) Levels
Time frame: At the end of each two month intervention
Blood Pressure
Time frame: At the end of each two month intervention
Fibrinogen
Time frame: At the end of each two month intervention
Insulin Levels
Time frame: At the end of each two month intervention
Lean Body Mass
Time frame: At the end of each two month intervention
Viral Load
Time frame: At the end of each two month intervention
CD4+ Lymphocytes
Time frame: At the end of each two month intervention
Interleukin-6 (IL-6) Levels
Time frame: At the end of each two month intervention
Hepatic Fat Content
Time frame: At the end of each two month intervention
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 11 May 2017.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Derived from this study: PubMed 35820631Bouzoni E, Perakakis N, Connelly MA, Angelidi AM, Pilitsi E, Farr O, Stefanakis K, Mantzoros CS. PCSK9 and ANGPTL3 levels correlate with hyperlipidemia in HIV-lipoatrophy, are regulated by fasting and are not affected by leptin administered in physiologic or pharmacologic doses. Metabolism. 2022 Sep;134:155265. doi: 10.1016/j.metabol.2022.155265. Epub 2022 Jul 9.
- Derived from this study: PubMed 21081243Magkos F, Brennan A, Sweeney L, Kang ES, Doweiko J, Karchmer AW, Mantzoros CS. Leptin replacement improves postprandial glycemia and insulin sensitivity in human immunodeficiency virus-infected lipoatrophic men treated with pioglitazone: a pilot study. Metabolism. 2011 Jul;60(7):1045-9. doi: 10.1016/j.metabol.2010.10.002. Epub 2010 Nov 16.
- Click here for more information about the Mantzoros Research Group.Link provided by the sponsor.
- Click here for more information about Beth Israel Deaconess Medical Center.Link provided by the sponsor.
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.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing r-metHuLeptin in people with HAART-induced Lipodystrophy and Metabolic Syndrome, run by Beth Israel Deaconess Medical Center 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 6 inclusion and 7 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 11 May 2017. 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. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Yes. Results are posted in the registry (first posted 6 Apr 2017). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
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?
Serum Lipid Levels (time frame: At the end of each two month intervention). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT00140244, which also lists 2 linked publications.
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 11 May 2017.