Ignite Creation Date:
2024-05-05 @ 6:33 PM
Last Modification Date:
2024-10-26 @ 9:35 AM
Study NCT ID:
NCT00508599
Status:
COMPLETED
Last Update Posted:
2024-03-12
First Post:
2007-07-26
Brief Title:
The Effects of Two Days of Bedrest on Insulin Resistance in Type 2 Diabetics
Sponsor:
University of New Mexico
Organization:
University of New Mexico
Study Overview
Official Title:
Effect of a 2-day Bed Rest on Metabolic and Cardiovascular Risk Factors in Type 2 Diabetic Patients
Status:
COMPLETED
Status Verified Date:
2024-03
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:
The hypothesis of this study is that bed rest in diabetic patients will result in a deterioration of metabolic control primarily glucose
Specific aims
1 To determine the change in metabolic control in type 2 diabetic individuals when three days of bed rest is compared to three days of activity
2 To determine the rate of progression of the deterioration in metabolic control and the magnitude of the decrease
3 To assess whether the anticipated deterioration of metabolic control has effects on several parameters of glucose metabolism including hyperglycemia and hypoglycemia
4 To determine the effects of bed rest on surrogate markers of atherosclerosis such as plasminogen activator inhibitor 1 PAI1 C-reactive protein CRP and homocysteine
5 To compare the effects of 48 hours of bed rest on orthostatic responses in type 2 diabetic patients and healthy non-diabetics
6 To make recommendations to the diabetic community to prevent metabolic deterioration during a 3 day hospitalization
Specific aims
1 To determine the change in metabolic control in type 2 diabetic individuals when three days of bed rest is compared to three days of activity
2 To determine the rate of progression of the deterioration in metabolic control and the magnitude of the decrease
3 To assess whether the anticipated deterioration of metabolic control has effects on several parameters of glucose metabolism including hyperglycemia and hypoglycemia
4 To determine the effects of bed rest on surrogate markers of atherosclerosis such as plasminogen activator inhibitor 1 PAI1 C-reactive protein CRP and homocysteine
5 To compare the effects of 48 hours of bed rest on orthostatic responses in type 2 diabetic patients and healthy non-diabetics
6 To make recommendations to the diabetic community to prevent metabolic deterioration during a 3 day hospitalization
Detailed Description:
The goal for all diabetic patients is to maintain their metabolic control as close to normal as possible to prevent the short and long term complications of diabetes Surgery of any type presents a unique challenge to the diabetic patient because two factors tend to worsen their metabolic control 1 the stress of the actual surgery and 2 the bed rest that follows the surgery Data has clearly shown that surgery increase counter regulatory hormones epinephrine glucagon growth hormone and cortisol What has not been studied is the effect of bed rest per se on metabolic control This is surprising because there are many studies in normal healthy people demonstrating that simple bed rest increases insulin resistance and worsens metabolic control
The proposed study will define the metabolic effects of simple three-day bed rest on metabolic control in healthy type 2 diabetic volunteers while evaluating the orthostatic response after bed rest All studies will be done in the inpatient General Clinical Research Center GCRC All volunteers will stop their oral antidiabetic medication before they enter the GCRC They will be placed on intravenous insulin to prevent severe metabolic deterioration and hyperglycemia The amount of insulin we have to give them to maintain metabolic control will be one measure of the effects of bed rest on metabolic control
Experimental Design and Methods
A crossover study in twenty healthy normal and twenty healthy type 2 diabetic subjects will be utilized Each subject will be admitted the the GCRC the night prior to beginning the study in order to insure metabolic stability at the start of the protocol Each subject will stay in the GCRC three full days three nights from the time of admission Each subject will be admitted on two separate occasions separated by at least a two week interval A diagram of the protocol is given below
The primary difference between the two admissions will be the amount of physical activity allowed each subject On the normal physical activity GCRC admission the subject will be encouraged to stay our of bed until hisher usual bedtime All procedures and meals will take place in the GCRC but in between times the subject will be encouraged to walk around the hospital and to carry out normal activities of daily living On the bed rest GCRC admission the subjects will be encouraged to stay in bed as much as possible and to use a bedside commode A tilt test was performed on the morning of the first day of each hospitalization and again 48 hours later The same testing will be done as in the normal activity admission
All medications that the volunteer usually takes at home will be continued in the hospital
The volunteer will be in the GCRC for three days Day 1 Day 2 and Day 3 The following tests will be done on the three days
Day 1 - Blood will drawn for fasting lipids glucose insulin and C-peptide as well as surrogate markers of atherosclerosis including PAI-1 IL-6 homocysteine fibrinogen and CRP In addition a tilt table test will be done to assess autonomic response to activity or bedrest
Day 2 - Blood will drawn for fasting lipids glucose insulin and C-peptide as well as surrogate markers of atherosclerosis including PAI-1 IL-6 homocysteine fibrinogen and CRP
Day 3 - Blood will drawn for fasting lipids glucose insulin and C-peptide as well as surrogate markers of atherosclerosis including PAI-1 IL-6 homocysteine fibrinogen and CRP In addition a tilt table test will be done to assess autonomic response to activity or bed rest
The proposed study will define the metabolic effects of simple three-day bed rest on metabolic control in healthy type 2 diabetic volunteers while evaluating the orthostatic response after bed rest All studies will be done in the inpatient General Clinical Research Center GCRC All volunteers will stop their oral antidiabetic medication before they enter the GCRC They will be placed on intravenous insulin to prevent severe metabolic deterioration and hyperglycemia The amount of insulin we have to give them to maintain metabolic control will be one measure of the effects of bed rest on metabolic control
Experimental Design and Methods
A crossover study in twenty healthy normal and twenty healthy type 2 diabetic subjects will be utilized Each subject will be admitted the the GCRC the night prior to beginning the study in order to insure metabolic stability at the start of the protocol Each subject will stay in the GCRC three full days three nights from the time of admission Each subject will be admitted on two separate occasions separated by at least a two week interval A diagram of the protocol is given below
The primary difference between the two admissions will be the amount of physical activity allowed each subject On the normal physical activity GCRC admission the subject will be encouraged to stay our of bed until hisher usual bedtime All procedures and meals will take place in the GCRC but in between times the subject will be encouraged to walk around the hospital and to carry out normal activities of daily living On the bed rest GCRC admission the subjects will be encouraged to stay in bed as much as possible and to use a bedside commode A tilt test was performed on the morning of the first day of each hospitalization and again 48 hours later The same testing will be done as in the normal activity admission
All medications that the volunteer usually takes at home will be continued in the hospital
The volunteer will be in the GCRC for three days Day 1 Day 2 and Day 3 The following tests will be done on the three days
Day 1 - Blood will drawn for fasting lipids glucose insulin and C-peptide as well as surrogate markers of atherosclerosis including PAI-1 IL-6 homocysteine fibrinogen and CRP In addition a tilt table test will be done to assess autonomic response to activity or bedrest
Day 2 - Blood will drawn for fasting lipids glucose insulin and C-peptide as well as surrogate markers of atherosclerosis including PAI-1 IL-6 homocysteine fibrinogen and CRP
Day 3 - Blood will drawn for fasting lipids glucose insulin and C-peptide as well as surrogate markers of atherosclerosis including PAI-1 IL-6 homocysteine fibrinogen and CRP In addition a tilt table test will be done to assess autonomic response to activity or bed rest
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