Ignite Creation Date:
2024-05-05 @ 11:07 AM
Last Modification Date:
2024-10-26 @ 9:05 AM
Study NCT ID:
NCT00006185
Status:
COMPLETED
Last Update Posted:
2010-03-02
First Post:
2000-08-22
Brief Title:
Underlying Abnormalities in Fat and Muscle Leading to Lipodystrophy Syndrome
Sponsor:
National Institute of Diabetes and Digestive and Kidney Diseases NIDDK
Organization:
National Institute of Diabetes and Digestive and Kidney Diseases NIDDK
Study Overview
Official Title:
Cellular Mechanisms for Metabolic Dysfunction in HIV
Status:
COMPLETED
Status Verified Date:
2010-03
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
With the advent of highly active anti-retroviral therapyHAART patients with HIV disease are developing a series of metabolic abnormalities including peripheral fat wasting increase in truncal fat high serum triglyceride levels insulina hormone that controls blood sugar resistance with an increased incidence of Type 2 Diabetes Mellitus and elevated blood pressure The premise of this study is that abnormalities in the ability of fat and muscle tissue to respond to the hormone insulin may be the cause of the diabetes mellitus high serum triglyceride levels and abnormal fat distribution The purpose of the study is to assess how insulin resistant patients with HIV disease are and if their fat and muscle tissue are responding abnormally to insulin This is done by administering insulin and taking small tissue samples of fat and muscle from the upper thigh and assessing how good insulin acts in these tissues
Patients with HIV disease will be admitted into the study after undergoing a screening medical history and examination Once patients qualify they will have their insulin resistance measured as well as the response of their fat and muscle to insulin blood levels of glucose sugar cholesterol and triglycerides will be measured body fat will be assessed using radiological tests a detailed medical history will be obtained to assess risk factors for developing this syndrome
Patients who are found to be insulin resistant will be offered a trial of an insulin sensitizing agent called Avandia for 6-12 weeks It is hoped that the Avandia will restore the bodys ability to respond normally to insulin as it does in patients with Diabetes and perhaps improve the fat abnormalities as well All the same measures will be performed at the end of the course of Avandia as were done at baseline
Patients who are not insulin resistant will be asked to come back yearly to assess whether they develop insulin resistance over time This study will continue to recruit patients over the next 3 years
Patients with HIV disease will be admitted into the study after undergoing a screening medical history and examination Once patients qualify they will have their insulin resistance measured as well as the response of their fat and muscle to insulin blood levels of glucose sugar cholesterol and triglycerides will be measured body fat will be assessed using radiological tests a detailed medical history will be obtained to assess risk factors for developing this syndrome
Patients who are found to be insulin resistant will be offered a trial of an insulin sensitizing agent called Avandia for 6-12 weeks It is hoped that the Avandia will restore the bodys ability to respond normally to insulin as it does in patients with Diabetes and perhaps improve the fat abnormalities as well All the same measures will be performed at the end of the course of Avandia as were done at baseline
Patients who are not insulin resistant will be asked to come back yearly to assess whether they develop insulin resistance over time This study will continue to recruit patients over the next 3 years
Detailed Description:
None
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None
Secondary IDs
| Secondary ID | Type | Domain | Link |
|---|---|---|---|
| DK49316-06 | None | None | None |