Ignite Creation Date:
2024-05-05 @ 11:49 AM
Last Modification Date:
2024-10-26 @ 9:14 AM
Study NCT ID:
NCT00145379
Status:
COMPLETED
Last Update Posted:
2013-05-20
First Post:
2005-09-02
Brief Title:
The Effect of Metformin in Overweight Patients With Dysregulated Type 1 Diabetes Mellitus
Sponsor:
Odense University Hospital
Organization:
Odense University Hospital
Study Overview
Official Title:
The Effect of Metformin in Overweight Patients With Dysregulated Type 1 Diabetes Mellitus
Status:
COMPLETED
Status Verified Date:
2013-05
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:
Patients suffering from diabetes through many years have a risk of developing late diabetic complications including changes in eyes kidney vessels and nerves Late complications can be postponed or avoided when assuring a good diabetes control ie sensible diet exercise frequent blood glucose measurements and a good medical treatment
Blood glucose regulation depends on two different factors ie the insulin need of the body and the amount of insulin in the body The amount of insulin in blood is decided by the amount of insulin infused daily whereas the insulin need depends on the patients weight physical activity and diet Overweight type 2 diabetes patients have a large insulin need and especially this need is decisive for their development of diabetes If these patients are treated with Metformin blood glucose decreases and the result is an easier weight loss for the patient Especially when these patients take this drug the development of late diabetic complications especially arteriosclerosis can be avoided or postponed
Whether these favourable effects of Metformin are also present in type 1 diabetic patients remains to be fully clarified but some studies have indicated that this is the case This results in a better regulation of diabetes on a smaller insulin dose than the one given to the patients before
Metformin probably takes effect by increasing the glucose uptake in muscles and by reducing the hepatic glucose production The drug usually has no side-effects but some patients do however suffer from abdominal pain small tendency to nausea loose defaecation and a metallic taste in the mouth These side-effects are often temporary
Project description
In total 50 type 1 diabetic patients are offered to participate in the project All are from the outpatient clinic at the Department of Endocrinology The project lasts 7 months divided as follows
1 An introductory period of one month introducing an optimisation of the insulin treatment
2 A 6 month period in which neither the patients nor the treating doctor know which medication is given with either T Metformin treatment twice daily or T Placebo lime twice daily together with the usual insulin treatment four times daily
Choice of either T Metformin or T Placebo will be made by draw and as stated above the drug type will be unknown for both the patient and the treating doctor in order to make sure that the investigation is as objective as possible
Throughout the examination period the patients are asked to measure blood glucose four times daily ie before main meals and before bed time These values will be used for regulating the fasting insulin dose with help from the treating doctor and for adjusting the daily insulin dose During the first and the last two days of the examination period we will also ask the patients to measure blood glucose at 03h00 for two days Those diurnal profiles will be included in the evaluation of the blood glucose control during the treatment period Furthermore the patients blood pressures are determined during 24 hours before and after the 6 months treatment period This will be carried out automatically by means of a blood pressure cuff around the arm connected to a small apparatus registering the values during 24 hours The apparatus can be taken home after installation at the outpatient clinic and can be carried around in a belt around the waist until next day where the apparatus will be dismantled
At the first and the last of 5 outpatient visits blood tests will be taken for evaluation of the long-term blood glucose kidney liver insulin and fat in blood and nocturnal urine must be collected and disposed in order to evaluate protein secretion and thereby kidney function
Blood glucose regulation depends on two different factors ie the insulin need of the body and the amount of insulin in the body The amount of insulin in blood is decided by the amount of insulin infused daily whereas the insulin need depends on the patients weight physical activity and diet Overweight type 2 diabetes patients have a large insulin need and especially this need is decisive for their development of diabetes If these patients are treated with Metformin blood glucose decreases and the result is an easier weight loss for the patient Especially when these patients take this drug the development of late diabetic complications especially arteriosclerosis can be avoided or postponed
Whether these favourable effects of Metformin are also present in type 1 diabetic patients remains to be fully clarified but some studies have indicated that this is the case This results in a better regulation of diabetes on a smaller insulin dose than the one given to the patients before
Metformin probably takes effect by increasing the glucose uptake in muscles and by reducing the hepatic glucose production The drug usually has no side-effects but some patients do however suffer from abdominal pain small tendency to nausea loose defaecation and a metallic taste in the mouth These side-effects are often temporary
Project description
In total 50 type 1 diabetic patients are offered to participate in the project All are from the outpatient clinic at the Department of Endocrinology The project lasts 7 months divided as follows
1 An introductory period of one month introducing an optimisation of the insulin treatment
2 A 6 month period in which neither the patients nor the treating doctor know which medication is given with either T Metformin treatment twice daily or T Placebo lime twice daily together with the usual insulin treatment four times daily
Choice of either T Metformin or T Placebo will be made by draw and as stated above the drug type will be unknown for both the patient and the treating doctor in order to make sure that the investigation is as objective as possible
Throughout the examination period the patients are asked to measure blood glucose four times daily ie before main meals and before bed time These values will be used for regulating the fasting insulin dose with help from the treating doctor and for adjusting the daily insulin dose During the first and the last two days of the examination period we will also ask the patients to measure blood glucose at 03h00 for two days Those diurnal profiles will be included in the evaluation of the blood glucose control during the treatment period Furthermore the patients blood pressures are determined during 24 hours before and after the 6 months treatment period This will be carried out automatically by means of a blood pressure cuff around the arm connected to a small apparatus registering the values during 24 hours The apparatus can be taken home after installation at the outpatient clinic and can be carried around in a belt around the waist until next day where the apparatus will be dismantled
At the first and the last of 5 outpatient visits blood tests will be taken for evaluation of the long-term blood glucose kidney liver insulin and fat in blood and nocturnal urine must be collected and disposed in order to evaluate protein secretion and thereby kidney function
Detailed Description:
None
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None