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| Tracking Information | |||||||||
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| First Received Date ICMJE | January 28, 2000 | ||||||||
| Last Updated Date | November 4, 2009 | ||||||||
| Start Date ICMJE | January 1976 | ||||||||
| Primary Completion Date | |||||||||
| Current Primary Outcome Measures ICMJE | |||||||||
| Original Primary Outcome Measures ICMJE |
Level of depression as measured by the Montgomery-Asberg Depression Rating Scale (MADRS). | ||||||||
| Change History | Complete list of historical versions of study NCT00001987 on ClinicalTrials.gov Archive Site | ||||||||
| Current Secondary Outcome Measures ICMJE | |||||||||
| Original Secondary Outcome Measures ICMJE |
The Hamilton Psychiatric Rating Scale for Anxiety (HAMA) and the Clinical Global Impression (CGI) severity scores. | ||||||||
| Descriptive Information | |||||||||
| Brief Title ICMJE | Genetic Studies of Insulin and Diabetes | ||||||||
| Official Title ICMJE | Studies of Molecular Genetics of Insulin Secretion, Insulin Action, and Diabetes Mellitus | ||||||||
| 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. |
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| Detailed Description | The purpose of this protocol is to enable us to obtain adequate blood or tissue samples to study the molecular mechanisms underlying various causes of insulin resistance and diabetes mellitus. Patients with evidence for insulin resistance will be eligible to participate in this study. We particularly focus our study on the following four groups of patients:
In addition, patients displaying unusual phenotypic features (i.e. presence of acanthosis nigricans) in association with hyperinsulinemia (i.e. fasting insulin levels greater than 30 microU/ml) or clinical diabetes mellitus may be eligible to be studied at NIH. The work-up will include all or some of the following studies: Routine biochemical profile Fasting insulin, glucose, HbA1c, lipid profile, lipoprotein profile, IGF-1 level, leptin level A panel of hormone levels: thyroid and sex hormones, pituitary hormones, adrenal hormones and growth hormone Blood samples for genetic studies Oral glucose tolerance test In vitro insulin or IGF-1 binding Autoantibodies to the insulin receptor if Type B insulin resistance is suspected The total quantity of blood collected is within the approved NIH guidelines appropriate to the individual's age and size. In addition, some subjects may undergo skin biopsy for the establishment of fibroblast cell lines. Some adult patients with lipoatrophy and lipodystrophy may be asked to undergo a muscle biopsy to broaden the molecular studies. Liver biopsies may be performed if clinically indicated in patients with lipoatrophy and lipodystrophy. DEXA analyses and anthropometric measurements are performed when medically indicated during the diagnosis and evaluation to correlate markers of insulin resistance with parameters of whole body composition. In a novel component of the study, we aim to study the biochemical and molecular changes that occur with standard therapies (such as high dose insulin, continuous insulin therapy, metformin, and TZD's) used for the treatment of insulin resistance and diabetes. |
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| Study Phase | |||||||||
| Study Type ICMJE | Observational | ||||||||
| Study Design ICMJE | |||||||||
| Condition ICMJE |
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| Intervention ICMJE | |||||||||
| Study Arms / Comparison Groups | |||||||||
| Publications * |
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* Includes publications given by the data provider as well as publications identified by National Clinical Trials Identifier (NCT ID) in Medline. |
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| Recruitment Information | |||||||||
| Recruitment Status ICMJE | Recruiting | ||||||||
| Enrollment ICMJE | 99999999 | ||||||||
| Completion Date | |||||||||
| Primary Completion Date | |||||||||
| Eligibility Criteria ICMJE |
At least one of the following is required: Hyperinsulinemia (i.e. greater than 30 microgramsU/mL). Clinical presence of diabetes. Phenotypic features suggesting a defect in glucose/lipid metabolism: Acanthosis nigricans; Lipoatrophy/lipodystrophy; Lipomatosis; Xanthomata; Fatty liver Family members of patients with known disease states of insulin action. |
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| Gender | Both | ||||||||
| Ages | |||||||||
| Accepts Healthy Volunteers | No | ||||||||
| Contacts ICMJE |
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| Location Countries ICMJE | United States | ||||||||
| Administrative Information | |||||||||
| NCT ID ICMJE | NCT00001987 | ||||||||
| Responsible Party | |||||||||
| Study ID Numbers ICMJE | 760006, 76-DK-0006 | ||||||||
| Study Sponsor ICMJE | National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK) | ||||||||
| Collaborators ICMJE | |||||||||
| Investigators ICMJE | |||||||||
| Information Provided By | National Institutes of Health Clinical Center (CC) | ||||||||
| Verification Date | August 2009 | ||||||||
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ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP |
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