Primary outcomeMedian· 12 weeks
Change in Insulin Sensitivity
| Group | Value (uU*10^-4*min*ml^-1) |
|---|---|
| rhGH + Rosi | 0.20 |
| rhGH Placebo + Rosi | 1.44 |
| rhGH + Rosi Placebo | -0.63 |
| Double Placebo | 0.14 |
Trial · Interventional
CompletedPhase 1/2Results postedRegistry dataGrowth Hormone and/or Rosiglitazone for HIV-Associated Increased Abdominal Fat and Insulin Resistance
Overview
- Status
- Completed
- Phase
- Phase 1/2
- Enrollment
- 77 participants (actual)
- Sponsor
- Weill Medical College of Cornell University · Other
- Design
- Randomized · Quadruple masking
- Countries
1 country
United States
- Start
- Mar 2005
- Primary completion
- Aug 2010
- Completion
- Aug 2010
- First posted
- 15 Aug 2005 (estimated)
- Last update posted
- 13 Feb 2014 (estimated)
- Conditions
- HIV-Associated Lipodystrophy Syndrome · Insulin Resistance · HIV Infections · Metabolic Syndrome X · Body Weight Changes
Timeline
1 trial · 1 completed · 1 with posted results
- Completed
- Ongoing
- Not yet recruiting
- Stopped
- Estimated dates (est.)
- Results posted
2005200620072008200920102011
- Ph 1/2
Growth Hormone and/or Rosiglitazone for HIV-Associated Increased Abdominal Fat and Insulin Resistance
NCT00130286Mar 2005 to Aug 2010
Registry summary
Text and fields below are the sponsor's entries at ClinicalTrials.gov, shown as posted.
The purpose of the study is to determine if the combination of recombinant human growth hormone plus rosiglitazone (an insulin-sensitizing drug) is safe and more effective than either drug alone (or no active therapy) for the treatment of fat accumulation in people with HIV infection and insulin resistance.
Interventions
- RosiglitazoneDrug
- Recombinant human growth hormone + rosiglitazoneDrug
Arms4
Experimental
rhGH + rosi
Recombinant human growth hormone + rosiglitazone
Experimental
rhGH placebo + rosi
Placebo for recombinant human growth hormone + rosiglitazone
Experimental
rhGH + rosi placebo
Recombinant human growth hormone + placebo for rosiglitazone
Placebo comparator
Double placebo
Placebo for recombinant human growth hormone + placebo for rosiglitazone
Primary outcomes1
Outcomes the sponsor listed as primary.
Change in Insulin Sensitivity
Time frame · 12 weeks
Registry description
Change in insulin sensitivity value from baseline to week 12 by frequently sampled intravenous glucose tolerance test This assessment was only conducted at baseline and week 12; therefore the change reflects the difference between these two time points.
Secondary outcomes(2)
Change in Visceral Adipose Tissue Volume
Time frame · 12 weeks
Registry description
Change in visceral adipose tissue volume from baseline to week 12 measured by whole body MRI Data are presented only for subjects who had MRI scans done at both time points.
Change in Subcutaneous Adipose Tissue Volume
Time frame · 12 weeks
Registry description
Change in subcutaneous adipose tissue volume from baseline to week 12 by whole body MRI Data are presented only for subjects who had MRI scans done at both time points.
Posted results
Values are shown as posted at ClinicalTrials.gov, with their units. PepBank has not converted, pooled or compared them.
Primary outcome results
Secondary and other outcome results(2)
Secondary outcomeMean· 12 weeks
Change in Visceral Adipose Tissue Volume
| Group | Value (L) | Spread |
|---|---|---|
| rhGH + Rosi | -1.13 | 1.41 |
| rhGH Placebo + Rosi | -0.19 | 0.69 |
| rhGH + Rosi Placebo | -1.15 | 0.81 |
| Double Placebo | -0.04 | 0.9 |
Secondary outcomeMean· 12 weeks
Change in Subcutaneous Adipose Tissue Volume
| Group | Value (L) | Spread |
|---|---|---|
| rhGH + Rosi | -0.11 | 3.33 |
| rhGH Placebo + Rosi | 0.74 | 1.86 |
| rhGH + Rosi Placebo | -0.38 | 1.23 |
| Double Placebo | -0.03 | 2.64 |
Adverse events, as posted
| Group | Deaths | Serious events | Other events |
|---|---|---|---|
| rhGH + RosiRecombinant human growth hormone + rosiglitazone Rosiglitazone: 4 mg tablet twice a day x 12 weeks (double-blind phase) Recombinant human growth hormone + rosiglitazone: Recombinant human growth hormone or placebo 3 mg s.c. x 12 weeks (double-blind phase) | – | 1 / 22 | 17 / 22 |
| rhGH Placebo + RosiPlacebo for recombinant human growth hormone + rosiglitazone Rosiglitazone: 4 mg tablet twice a day x 12 weeks (double-blind phase) Recombinant human growth hormone + rosiglitazone: Recombinant human growth hormone or placebo 3 mg s.c. x 12 weeks (double-blind phase) | – | 1 / 19 | 11 / 18 |
| rhGH + Rosi PlaceboRecombinant human growth hormone + placebo for rosiglitazone Rosiglitazone: 4 mg tablet twice a day x 12 weeks (double-blind phase) Recombinant human growth hormone + rosiglitazone: Recombinant human growth hormone or placebo 3 mg s.c. x 12 weeks (double-blind phase) | – | 0 / 17 | 14 / 15 |
| Double PlaceboPlacebo for recombinant human growth hormone + placebo for rosiglitazone Rosiglitazone: 4 mg tablet twice a day x 12 weeks (double-blind phase) Recombinant human growth hormone + rosiglitazone: Recombinant human growth hormone or placebo 3 mg s.c. x 12 weeks (double-blind phase) | – | 3 / 19 | 9 / 17 |
Each cell reads participants affected / participants at risk, as the registry posted them.
Registry data comes from ClinicalTrials.gov. Study results come from studies, not from the registry. How PepBank works
Studies1
Studies that cite this trial.
More studies
1 study on this page
Indexing hint: Randomized controlled trial · 2013
Recombinant human growth hormone and rosiglitazone for abdominal fat accumulation in HIV-infected patients with insulin resistance: a randomized, double-blind, placebo-controlled, factorial trial.
Glesby et al. 2013PloS onecited by 10
PMID 23593417PMC3625151DOI 10.1371/journal.pone.0061160PUB-23593417
CC BY
Other registry references
References listed at the registry that are not in PepBank. They link to PubMed.
- DerivedKotler DP, He Q, Engelson ES, Albu JB, Glesby MJ. The effect of recombinant human growth hormone with or without rosiglitazone on hepatic fat content in HIV-1-infected individuals: a randomized clinical trial. Antivir Ther. 2016;21(2):107-16. doi: 10.3851/IMP2927. Epub 2014 Dec 23. PMID 25536669
Eligibility
Who could join, as posted.
- Sex
- All
- Age
- from 18 Years up to 65 Years
- Healthy volunteers
- Not accepted
Inclusion and exclusion criteria, as posted
Inclusion Criteria:
* HIV-infected
* On stable Food and Drug Administration (FDA)-approved antiretrovirals for at least 8 weeks
* Excess abdominal fat based on waist and hip measurements done at the screening visit. \[waist greater than 34.7 inches (men) or 29.6 inches (women) and waist to hip ratio greater than 0.95 (men) or 0.9 (women)\]
* Evidence of insulin resistance (based on fasting glucose and insulin levels done at screening)
* Triglycerides less than 750 mg/dL
Exclusion Criteria:
* Pregnancy
* Active AIDS-defining infection or other acute illness, within 30 days of entry.
* Active cancer (except for localized Kaposi's sarcoma) or active brain tumor
* Any diagnosis of pancreatitis, carpal tunnel syndrome, diabetes, angina, coronary artery disease, or disorder associated with fluid retention (examples: cirrhosis, congestive heart failure)
* Untreated or uncontrolled high blood pressure, within 30 days of entry.
* Within 12 weeks of study entry, use of the following:
* Obesity (fat-reducing) drugs.
* Anti-diabetic or insulin-sensitizing drugs (examples: rosiglitazone, pioglitazone, or metformin).
* Systemic glucocorticoids (example: prednisone).
* Growth hormone or any medication for AIDS-associated wasting.
* Systemic chemotherapy, interferon, or radiation therapy.
* Androgenic agents \[examples: nandrolone, oxandrolone (Oxandrin) (testosterone replacement therapy is permitted if started more than 30 days before entry)\]
* Appetite stimulants (Marinol, Megace, Periactin).
* Use of cholesterol lowering drugs, unless started more than 12 weeks before entry
* Inability to have a magnetic resonance imaging (MRI) scan performed (examples: cardiac pacemaker, intracranial aneurysm clips)
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