Ignite Creation Date:
2024-05-05 @ 10:17 AM
Last Modification Date:
2024-10-26 @ 9:02 AM
Study NCT ID:
NCT00001987
Status:
RECRUITING
Last Update Posted:
2024-07-15
First Post:
2000-01-28
Brief Title:
Genetic Studies of Insulin and Diabetes
Sponsor:
National Institute of Diabetes and Digestive and Kidney Diseases NIDDK
Organization:
National Institutes of Health Clinical Center CC
Study Overview
Official Title:
Natural History of Disorders of Insulin Resistance
Status:
RECRUITING
Status Verified Date:
2024-09-11
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:
The study will allow researchers to obtain blood plasma DNA and RNA for genetic studies of insulin There will be a focus on the causes of insulin resistance and diabetes mellitus Insulin is a hormone found in the body that controls the level of sugar in the blood Insulin resistance refers to conditions like diabetes when insulin does not work properly In this study researchers would like to compare patients with diabetes and other forms of insulin resistance to normal individuals The study will investigate how insulin attaches to cells
Researchers will take 4 to 6 ounces 100-150 ml of blood from adult patients and may request up to 12 ounces one unit of blood if necessary Skin samples may be taken for a biopsy if further genetic testing is necessary In addition some patients may be asked not to eat for up to 72 hours prior to testing
Researchers will take 4 to 6 ounces 100-150 ml of blood from adult patients and may request up to 12 ounces one unit of blood if necessary Skin samples may be taken for a biopsy if further genetic testing is necessary In addition some patients may be asked not to eat for up to 72 hours prior to testing
Detailed Description:
Study Description
Insulin is the key hormone responsible for regulating the level of glucose in plasma In several disease states eg obesity type 2 diabetes and acromegaly the target cells are resistant to insulin action Insulin resistance leads to metabolic complications including diabetes dyslipidemia cardiovascular disease non-alcoholic fatty liver disease and reproductive dysfunction The intramural research program of the NIDDK has a long history of studying patients with rare disorders of extreme insulin resistance We use what is learned from these rare patients both to develop therapeutics for rare diseases and to apply what is learned to understand more common forms of insulin resistance
Objectives
Primary Objectives 1 To understand the pathophysiology of insulin resistance and its relationship to cardiovascular disease 2 To study the molecular genetics underlying various causes of insulin resistance and diabetes mellitus and 3 To understand the natural history of insulin resistance disorders including their response to FDA approved therapies
Endpoints
Primary Endpoint Genetic causes of insulin resistance
Secondary Endpoints Diabetes control hemoglobin A1c and complications rates of micro- and macrovascular disease
Insulin is the key hormone responsible for regulating the level of glucose in plasma In several disease states eg obesity type 2 diabetes and acromegaly the target cells are resistant to insulin action Insulin resistance leads to metabolic complications including diabetes dyslipidemia cardiovascular disease non-alcoholic fatty liver disease and reproductive dysfunction The intramural research program of the NIDDK has a long history of studying patients with rare disorders of extreme insulin resistance We use what is learned from these rare patients both to develop therapeutics for rare diseases and to apply what is learned to understand more common forms of insulin resistance
Objectives
Primary Objectives 1 To understand the pathophysiology of insulin resistance and its relationship to cardiovascular disease 2 To study the molecular genetics underlying various causes of insulin resistance and diabetes mellitus and 3 To understand the natural history of insulin resistance disorders including their response to FDA approved therapies
Endpoints
Primary Endpoint Genetic causes of insulin resistance
Secondary Endpoints Diabetes control hemoglobin A1c and complications rates of micro- and macrovascular disease
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
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 |
|---|---|---|---|
| 76-DK-0006 | None | None | None |