Genetic Studies of Insulin and Diabetes
Trial statusRecruiting
Trial phaseNot listed
Trial typeObservational
Biological sexAll
Age6-120
SponsorNational Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)
About this trial
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.
Eligibility criteria
This trial accepts healthy volunteersQualifiers
Patients with various syndromes of lipodystrophy
Patients with known or suspected mutations on the insulin receptor gene
Patients with known or suspected autoantibodies to the insulin receptor
Patients with other severe forms of insulin resistance
Disqualifiers
Patients with evidence for insulin resistance or a disorder associated with severe insulin resistance
Family members of patients, above
Healthy control subjects Cohort 1
Current use of prescription or non-prescription medication. Certain exceptions are permitted, including topical medications, vitamins, and hormonal contraceptives. Other medications may be permitted at the discretion of the investigators.
Trial population
Subjects with severe insulin resistance disorders.
Trial design
Design model
Cohort
Time perspective
Prospective
Treatments tested in this trial
HR-pQCT scan
DeviceHR-pQCT is a non-invasive, low-dose three-dimensional imaging method used to evaluate volumetric bone mineral density and bone microarchitecture of peripheral skeletal sites, including distal radius and distal tibia. HR-pQCT has an ability to differentiate between cortical and trabecular bone compartments providing density and structure parameters.
Treatment groups
1,200 Participants
are divided into 2 treatment groupsGroup A: Healthy Volunteers1 intervention
Group B: Patients with severe insulin resistance1 intervention
Trial outcomes
Primary outcomes
1
Diabetes control
To help prevent additional health issues associated with poor glucose and insulin levels.
Time frame
every 6-12 months2
Genetics of insulin resistance
To discover the cause of the insulin resistance to better assist with treatment for it.
Time frame
End of Study3
Pathophysiology of insulin resistance and its relationship to cardiovascular disease.
To understand the pathophysiology of insulin resistance and its relationship to cardiovascular disease.
Time frame
End of study4
Obtain tissue samples for ex vivo studies.
To understand physiology and pathophysiology of insulin resistance and develop possible treatments.
Time frame
End of studySponsors and contacts
Click on the lead sponsor to view all of their trials.
Source ClinicalTrials.gov