Type 2 DiabetesNCT00508599
The Effects of Two Days of Bedrest on Insulin Resistance in Type 2 Diabetics
A study testing Study 2 (48 hours of complete bed rest) in people with Type 2 Diabetes and Insulin Resistance, run by University of New Mexico at 1 site in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 21 to 75 yearsHealthy volunteers can take part
- Conditions the study is for
- Type 2 Diabetes, Insulin Resistance
- What is being tested?
- Study 2 (48 hours of complete bed rest)
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 16 participants
- Where
- 1 siteUnited States
- Study dates
- Jan 2003to Jan 2006
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 21 to 75 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Type 2 diabetic for at least 6 months.
- Healthy volunteers.
- Type 2 diabetic subjects will have some nominal ability to secrete endogenous insulin as demonstrated by a post-stimulation C-peptide concentration of at least 6 ng/ml.
- All subjects will be mentally fit to give informed consent.
- Hemoglobin A1C value below 11% (normal range = 4.4-5.8%) prior to study enrollment.
Who cannot join
- Hemoglobin A1c values > 11%
- Severe cardiovascular, hepatic, or renal disease
- Past current history of drug or alcohol abuse
- Diabetic gastroparesis
- Uncontrolled hypertension ( > 140-90 mmHg)
- Marked hyperlipidemia (serum LDL > 158mg/dl, or serum TG >691 mg/dl)
Show all 13Show fewer
- Medications that interfere with glucose homeostasis
- Coumadin or other anticoagulation medications
- History of thrombosis or thrombophlebitis
- Current malignancy
- Smoker
- Pregnancy
- Contact precautions
Trial locations and contacts
1 site in 1 country.
United States1 site
University of New Mexico, Clinical Translational Science Center
Albuquerque, New Mexico, 87131
About this study
Official title: Effect of a 2-day Bed Rest on Metabolic and Cardiovascular Risk Factors in Type 2 Diabetic Patients
The hypothesis of this study is that bed rest in diabetic patients will result in a deterioration of metabolic control (primarily glucose).
Specific aims:
- 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;
- To determine the rate of progression of the deterioration in metabolic control and the magnitude of the decrease;
- To assess whether the anticipated deterioration of metabolic control has effects on several parameters of glucose metabolism, including hyperglycemia and hypoglycemia;
- 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.
- To compare the effects of 48 hours of bed rest on orthostatic responses in type 2 diabetic patients, and healthy non-diabetics.
- To make recommendations to the diabetic community to prevent metabolic deterioration during a 3 day hospitalization.
Read the 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 his/her 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.
- Conditions
- Type 2 Diabetes, Insulin Resistance
- Being tested
- Study 2 (48 hours of complete bed rest)
- Keywords
- type 2 diabetes, bed rest, insulin resistance, insulin, glucose, orthostatic response
- Medical subject headings
- Diabetes Mellitus, Type 2, Insulin Resistance
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Study 2 (48 hours of complete bed rest)Other
Effects of 48 hours of bed rest on insulin resistance in type 2 diabetic subjects.
| Study group | Role | What they receive |
|---|---|---|
| 1 | No intervention | Study 1 is the control arm in which participants continue with their normal activity. |
| 2. | Experimental | Study 2 consists of 48 hours of complete bed rest. Receives: Other: Study 2 (48 hours of complete bed rest) |
What is being measured
The primary outcome is the main question the study is designed to answer.
Insulin resistance and orthostatic response
Measured: 48 hours bed rest and 48 hours activity
Secondary outcomes (1)
Change in glucose, insulin, and orthostatic impairment.
Measured: 48 hours of bed rest and 48 hours of Activity
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted30 Jul 2007 (estimated)
- Study startJan 2003
- Primary completionJan 2004
- Study completionJan 2006
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (11)Papers the sponsor has linked to this study.
- Other trials for Type 2 DiabetesStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- None (open label)
- Enrolment
- 16 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of New Mexico
- Sponsor type
- University, hospital or other
- Investigators
- David S Schade, M.D., Principal investigator, University of New Mexico
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00508599
- Sponsor's protocol ID
- 03-163
- Status last verified
- Mar 2024
- First submitted
- 26 Jul 2007
- Last updated
- 12 Mar 2024
- Results posted
- No
- Data monitoring committee
- Yes
Publications
Smorawinski J, Kaciuba-Uscilko H, Nazar K, Kubala P, Kaminska E, Ziemba AW, Adrian J, Greenleaf JE. Effects of three-day bed rest on metabolic, hormonal and circulatory responses to an oral glucose load in endurance or strength trained athletes and untrained subjects. J Physiol Pharmacol. 2000 Jun;51(2):279-89.
PubMed 10898100Nichiporuk IA, Evdokimov VV, Erasova VI, Smirnov OA, Goncharova AG, Vassilieva GYu, Vorobiev DV. Male reproductive system in conditions of bed-rest in a head-down tilt. J Gravit Physiol. 1998 Jul;5(1):P101-2.
PubMed 11542307Stuart CA, Shangraw RE, Prince MJ, Peters EJ, Wolfe RR. Bed-rest-induced insulin resistance occurs primarily in muscle. Metabolism. 1988 Aug;37(8):802-6. doi: 10.1016/0026-0495(88)90018-2.
PubMed 3043146Yanagibori R, Suzuki Y, Kawakubo K, Makita Y, Gunji A. Carbohydrate and lipid metabolism after 20 days of bed rest. Acta Physiol Scand Suppl. 1994;616:51-7.
PubMed 8042526Blanc S, Normand S, Pachiaudi C, Fortrat JO, Laville M, Gharib C. Fuel homeostasis during physical inactivity induced by bed rest. J Clin Endocrinol Metab. 2000 Jun;85(6):2223-33. doi: 10.1210/jcem.85.6.6617.
PubMed 10852455Mikines KJ, Richter EA, Dela F, Galbo H. Seven days of bed rest decrease insulin action on glucose uptake in leg and whole body. J Appl Physiol (1985). 1991 Mar;70(3):1245-54. doi: 10.1152/jappl.1991.70.3.1245.
PubMed 2032990Yanagibori R, Kondo K, Suzuki Y, Kawakubo K, Iwamoto T, Itakura H, Gunji A. Effect of 20 days' bed rest on the reverse cholesterol transport system in healthy young subjects. J Intern Med. 1998 Apr;243(4):307-12. doi: 10.1046/j.1365-2796.1998.00303.x.
PubMed 9627145Valek J, Valkova L, Vlasakova Z, Topinka V. Increased fibrinogen levels in the offspring of hypertensive men. Relation with hyperinsulinemia and the metabolic syndrome. Arterioscler Thromb Vasc Biol. 1995 Dec;15(12):2229-33. doi: 10.1161/01.atv.15.12.2229.
PubMed 7489247Gough SC, Rice PJ, McCormack L, Chapman C, Grant PJ. The relationship between plasminogen activator inhibitor-1 and insulin resistance in newly diagnosed type 2 diabetes mellitus. Diabet Med. 1993 Aug-Sep;10(7):638-42. doi: 10.1111/j.1464-5491.1993.tb00137.x.
PubMed 8403825Schneider SM, Robergs RA, Amorim FT, de Serna DG, Duran-Valdez EE, Schade DS. Impaired orthostatic response in patients with type 2 diabetes mellitus after 48 hours of bed rest. Endocr Pract. 2009 Mar;15(2):104-10. doi: 10.4158/EP.15.2.104.
PubMed 19289319Duran-Valdez E, de Serna DG, Schneider S, Amorim F, Burge M, Schade DS. Metabolic effects of 2 days of strict bed rest. Endocr Pract. 2008 Jul-Aug;14(5):564-9. doi: 10.4158/EP.14.5.564.
PubMed 18753098
Study at a glance
From the registry record, last updated by the sponsor on 12 Mar 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effect of a 2-day Bed Rest on Metabolic and Cardiovascular Risk Factors in Type 2 Diabetic Patients
- ClinicalTrials.gov ID
- NCT00508599
- Acronym / sponsor ID
- 03-163
- Conditions
- Type 2 Diabetes, Insulin Resistance
- Keywords
- type 2 diabetes, bed rest, insulin resistance, insulin, glucose, orthostatic response
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 16 participants (actual)
- Lead sponsor
- University of New MexicoUniversity, hospital or other
- Study start
- Jan 2003 (actual)
- Primary completion
- Jan 2004 (actual)
- Study completion
- Jan 2006 (actual)
- First posted
- 30 Jul 2007 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The hypothesis of this study is that bed rest in diabetic patients will result in a deterioration of metabolic control (primarily glucose).
Specific aims:
- 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;
- To determine the rate of progression of the deterioration in metabolic control and the magnitude of the decrease;
- To assess whether the anticipated deterioration of metabolic control has effects on several parameters of glucose metabolism, including hyperglycemia and hypoglycemia;
- 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.
- To compare the effects of 48 hours of bed rest on orthostatic responses in type 2 diabetic patients, and healthy non-diabetics.
- 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 his/her 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 design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| 1 | No intervention | –Study 1 is the control arm in which participants continue with their normal activity. |
| 2. | Experimental | Other: Study 2 (48 hours of complete bed rest)Study 2 consists of 48 hours of complete bed rest. |
Who may qualify
- Ages
- 21 to 75 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- Type 2 diabetic for at least 6 months.
- Healthy volunteers.
- Type 2 diabetic subjects will have some nominal ability to secrete endogenous insulin as demonstrated by a post-stimulation C-peptide concentration of at least 6 ng/ml.
- All subjects will be mentally fit to give informed consent.
- Hemoglobin A1C value below 11% (normal range = 4.4-5.8%) prior to study enrollment.
Key exclusion criteria (13 listed)
- Hemoglobin A1c values > 11%
- Severe cardiovascular, hepatic, or renal disease
- Past current history of drug or alcohol abuse
- Diabetic gastroparesis
- Uncontrolled hypertension ( > 140-90 mmHg)
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Study 2 (48 hours of complete bed rest)Effects of 48 hours of bed rest on insulin resistance in type 2 diabetic subjects. | Other | 2. |
Primary outcome
Insulin resistance and orthostatic response
Time frame: 48 hours bed rest and 48 hours activity
1 secondary outcome
Change in glucose, insulin, and orthostatic impairment.
Time frame: 48 hours of bed rest and 48 hours of Activity
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 12 Mar 2024.
- Background: PubMed 10898100Smorawinski J, Kaciuba-Uscilko H, Nazar K, Kubala P, Kaminska E, Ziemba AW, Adrian J, Greenleaf JE. Effects of three-day bed rest on metabolic, hormonal and circulatory responses to an oral glucose load in endurance or strength trained athletes and untrained subjects. J Physiol Pharmacol. 2000 Jun;51(2):279-89.
- Background: PubMed 11542307Nichiporuk IA, Evdokimov VV, Erasova VI, Smirnov OA, Goncharova AG, Vassilieva GYu, Vorobiev DV. Male reproductive system in conditions of bed-rest in a head-down tilt. J Gravit Physiol. 1998 Jul;5(1):P101-2.
- Background: PubMed 3043146Stuart CA, Shangraw RE, Prince MJ, Peters EJ, Wolfe RR. Bed-rest-induced insulin resistance occurs primarily in muscle. Metabolism. 1988 Aug;37(8):802-6. doi: 10.1016/0026-0495(88)90018-2.
- Background: PubMed 8042526Yanagibori R, Suzuki Y, Kawakubo K, Makita Y, Gunji A. Carbohydrate and lipid metabolism after 20 days of bed rest. Acta Physiol Scand Suppl. 1994;616:51-7.
- Background: PubMed 10852455Blanc S, Normand S, Pachiaudi C, Fortrat JO, Laville M, Gharib C. Fuel homeostasis during physical inactivity induced by bed rest. J Clin Endocrinol Metab. 2000 Jun;85(6):2223-33. doi: 10.1210/jcem.85.6.6617.
- Background: PubMed 2032990Mikines KJ, Richter EA, Dela F, Galbo H. Seven days of bed rest decrease insulin action on glucose uptake in leg and whole body. J Appl Physiol (1985). 1991 Mar;70(3):1245-54. doi: 10.1152/jappl.1991.70.3.1245.
- Background: PubMed 9627145Yanagibori R, Kondo K, Suzuki Y, Kawakubo K, Iwamoto T, Itakura H, Gunji A. Effect of 20 days' bed rest on the reverse cholesterol transport system in healthy young subjects. J Intern Med. 1998 Apr;243(4):307-12. doi: 10.1046/j.1365-2796.1998.00303.x.
- Background: PubMed 7489247Valek J, Valkova L, Vlasakova Z, Topinka V. Increased fibrinogen levels in the offspring of hypertensive men. Relation with hyperinsulinemia and the metabolic syndrome. Arterioscler Thromb Vasc Biol. 1995 Dec;15(12):2229-33. doi: 10.1161/01.atv.15.12.2229.
- Background: PubMed 8403825Gough SC, Rice PJ, McCormack L, Chapman C, Grant PJ. The relationship between plasminogen activator inhibitor-1 and insulin resistance in newly diagnosed type 2 diabetes mellitus. Diabet Med. 1993 Aug-Sep;10(7):638-42. doi: 10.1111/j.1464-5491.1993.tb00137.x.
- Derived from this study: PubMed 19289319Schneider SM, Robergs RA, Amorim FT, de Serna DG, Duran-Valdez EE, Schade DS. Impaired orthostatic response in patients with type 2 diabetes mellitus after 48 hours of bed rest. Endocr Pract. 2009 Mar;15(2):104-10. doi: 10.4158/EP.15.2.104.
- Derived from this study: PubMed 18753098Duran-Valdez E, de Serna DG, Schneider S, Amorim F, Burge M, Schade DS. Metabolic effects of 2 days of strict bed rest. Endocr Pract. 2008 Jul-Aug;14(5):564-9. doi: 10.4158/EP.14.5.564.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
David S Schade, M.D. principal investigator
University of New Mexico
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Study 2 (48 hours of complete bed rest) in people with Type 2 Diabetes and Insulin Resistance, run by University of New Mexico at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 13 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 12 Mar 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Insulin resistance and orthostatic response (time frame: 48 hours bed rest and 48 hours activity). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT00508599, which also lists 11 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 12 Mar 2024.