The Effects of Two Days of Bedrest on Insulin Resistance in Type 2 Diabetics (NCT00508599) | Clinical Trial Compass
CompletedNot Applicable
The Effects of Two Days of Bedrest on Insulin Resistance in Type 2 Diabetics
United States16 participantsStarted 2003-01
Plain-language 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.
Who can participate
Age range
21 Years – 75 Years
Sex
ALL
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
Inclusion Criteria:
* 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.
Exclusion Criteria:
* 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)
* Medications that interfere with glucose homeostasis
* Coumadin or other anticoagulation medications
* History of thrombosis or thrombophlebitis
* Current malignancy
* Smoker
* Pregnancy
* Contact precautions
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.
What they're measuring
1
Insulin resistance and orthostatic response
Timeframe: 48 hours bed rest and 48 hours activity