Genetic Variants Replication Study Associated With Dependence on Sulfonylurea in Participants With Type 2 Diabetes
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|ClinicalTrials.gov Identifier: NCT04123587|
Recruitment Status : Recruiting
First Posted : October 11, 2019
Last Update Posted : October 11, 2019
|Condition or disease||Intervention/treatment||Phase|
|Diabetes Mellitus||Drug: discontinuation of Sulfonylureas||Phase 4|
Sulfonylurea, one of the oral hypoglycemic agents, is the oldest and most widely used drug. The use of sulfonylurea was overwhelming compared to metformin especially in East Asia, where insulin secretion was notable during the pathophysiology of type 2 diabetes. However, sulfonylurea causes hypoglycemia and weight gain, increases cardiovascular disease and mortality compared to other oral preparations. With the recent development of other oral hypoglycemic agents for lowering blood glucose without the risk of hypoglycemia and with cardiovascular protection, sulfonylurea is in a decreasing state of use worldwide.
But some patients tend to be highly dependent on sulfonylurea for blood glucose control. It suggests that there will be a group of patients whose the action of sulfonylurea is strongly influenced by genetic factor, since insulin secretion of pancreatic beta cells is very hereditary, genetic variations that increase the risk of type 2 diabetes are found mainly in genes related to beta cell dysfunction rather than insulin resistance, and the more risk variants of type 2 diabetes, the less likely the effect of sulfonylurea is.
The investigators had performed whole exome sequencing in patients showing dependence on sulfonylurea and identified tens of candidate variants.
In this study, the investigators will select patients with dependence on sulfonylurea by prospective intervention (by discontinuing and resuming sulfonylurea) and perform genetic tests.
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||58 participants|
|Intervention Model:||Single Group Assignment|
|Masking:||None (Open Label)|
|Official Title:||Genetic Variants Replication Study Associated With Dependence on Sulfonylurea in Participants With Type 2 Diabetes|
|Actual Study Start Date :||September 10, 2019|
|Estimated Primary Completion Date :||August 2020|
|Estimated Study Completion Date :||August 2021|
Sulfonylurea is replaced by alternative oral hypoglycemic agent.
Drug: discontinuation of Sulfonylureas
Other Name: other oral anti-diabetics instead of sulfonylureas
- the list of previously found candidate variants which are observed in the slufonylurea-dependent patients but not in the non-dependent patients [ Time Frame: 20 weeks ]Dependency on sulfonylurea-dependency is determined according to changes in HbA1c by use of sulfonylurea. The 'previously found candidate variants' are the results from whole exome sequencing in patients showing dependence on sulfonylurea as a screening before.
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04123587
|Contact: Han Na Jang, MDfirstname.lastname@example.org|
|Korea, Republic of|
|Seoul National University Hospital||Recruiting|
|Seoul, Korea, Republic of, 110-144|
|Contact: Hye Seung Jung +82-2-2072-0240 email@example.com|
|Principal Investigator:||Hye Seung Jung, MD||Seoul National University Hospital|