Diabetes Clinical Trial
Official title:
Predictive and Protective Factors in the Cause of Diabetes: A Study in Twins
This study, conducted at St. Bartholomew's Hospital, London, England, will determine whether
cells passed from mother to offspring during pregnancy increase or decrease the child's risk
of developing type 1 diabetes. Previous research has shown that certain cells that can be
passed from mothers to their children during pregnancy may affect the child's chance of
developing other autoimmune diseases. The cells from the mother may persist in the child's
blood for years after birth and stimulate the child's immune system in such a way that may
either increase or decrease the chance of the child developing diabetes. This study will
determine whether these cells are present in identical twins, where only one of the twins
has type 1 diabetes.
Participants in the British Diabetic Twins Study in England may be eligible to participate.
Of each twin pair in the study, one must have type 1 diabetes and the other must be free of
the disease. The twins' mother must be alive and willing to provide a blood sample. For
female twins only, their children must be alive and willing to provide either a blood or a
buccal cell sample (cheek swab).
Participants undergo the following procedures:
- Both twins in each twin pair provide a blood sample collected on a single occasion.
- The mother of each twin pair provides a blood sample collected on a single occasion.
- Children of female twins provide a single sample from either the mouth or blood. For
children younger than 12 years of age, a cell sample is collected from the inside of
the mouth (buccal) using a toothbrush. The child strokes the inside (cheek) of the
mouth with the toothbrush ten times on each side, spits this into a collection vial,
immediately rinses the mouth with water and adds this rinse to the sample collection
vial. Children over 12 years of age may provide either a buccal cell sample or a blood
sample.
Status | Completed |
Enrollment | 240 |
Est. completion date | |
Est. primary completion date | September 2007 |
Accepts healthy volunteers | Accepts Healthy Volunteers |
Gender | Both |
Age group | N/A and older |
Eligibility |
- INCLUSION/EXCLUSION CRITERIA: The twin subjects who are the focus of this study will be greater than or equal to 12 years of age and diabetes discordance must have been present for greater than 5 years. The subjects must be able to understand and sign the informed consent documents, and thus severe mental incapacity is an exclusion criterion. Female twins must not be currently pregnant or have had a miscarriage or abortion. Identical twin pairs (female or male) must not have undergone an organ or bone marrow transplantation, or a blood transfusion at any time in their lives. There are no other health status criteria for participating in this study, except as noted above. Patients may have other preexisting conditions. There are no age limits for the offspring of the twins. Subjects will not be excluded based on gender, ethnicity, race or religion. |
N/A
Country | Name | City | State |
---|---|---|---|
United Kingdom | St. Bartholomew's Hospital | London |
Lead Sponsor | Collaborator |
---|---|
National Institute of Environmental Health Sciences (NIEHS) |
United Kingdom,
Christau B, Kromann H, Christy M, Andersen OO, Nerup J. Incidence of insulin-dependent diabetes mellitus (0--29 years at onset) in Denmark. Acta Med Scand Suppl. 1979;624:54-60. — View Citation
Gottlieb MS, Root HF. Diabetes mellitus in twins. Diabetes. 1968 Nov;17(11):693-704. — View Citation
Tisch R, McDevitt H. Insulin-dependent diabetes mellitus. Cell. 1996 May 3;85(3):291-7. Review. — View Citation
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