The Effects of Two Days of Bedrest on Insulin Resistance in Type 2 Diabetics

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT00508599
Recruitment Status : Completed
First Posted : July 30, 2007
Last Update Posted : April 23, 2008
Information provided by:
University of New Mexico

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.

Condition or disease Intervention/treatment Phase
Type 2 Diabetes Insulin Resistance Other: Study 2 (48 hours of complete bed rest) Not Applicable

  Show Detailed Description

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 16 participants
Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Effect of a 2-Day Bed Rest on Metabolic and Cardiovascular Risk Factors in Type 2 Diabetic Patients
Study Start Date : May 2003
Actual Primary Completion Date : October 2004
Actual Study Completion Date : February 2006

Resource links provided by the National Library of Medicine

Drug Information available for: Insulin
U.S. FDA Resources

Arm Intervention/treatment
No Intervention: 1
Study 1 is the control arm in which participants continue with their normal activity.
Experimental: 2.
Study 2 consists of 48 hours of complete bed rest.
Other: Study 2 (48 hours of complete bed rest)
Effects of 48 hours of bed rest on insulin resistance in type 2 diabetic subjects.

Primary Outcome Measures :
  1. Insulin resistance and orthostatic response [ Time Frame: 48 hours bed rest and 48 hours activity ]

Secondary Outcome Measures :
  1. Change in glucose, insulin, and orthostatic impairment. [ Time Frame: 48 hours of bed rest and 48 hours of Activity ]

Information from the National Library of Medicine

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Ages Eligible for Study:   21 Years to 75 Years   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes

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

Information from the National Library of Medicine

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 identifier (NCT number): NCT00508599

United States, New Mexico
University of New Mexico, Clinical Translational Science Center
Albuquerque, New Mexico, United States, 87131
Sponsors and Collaborators
University of New Mexico
Principal Investigator: David S Schade, M.D. University of New Mexico


Publications automatically indexed to this study by Identifier (NCT Number):
Responsible Party: David S. Schade, M.D., University of New Mexico Identifier: NCT00508599     History of Changes
Other Study ID Numbers: 03-163
First Posted: July 30, 2007    Key Record Dates
Last Update Posted: April 23, 2008
Last Verified: April 2008

Keywords provided by University of New Mexico:
type 2 diabetes
bed rest
insulin resistance
orthostatic response

Additional relevant MeSH terms:
Diabetes Mellitus, Type 2
Insulin Resistance
Diabetes Mellitus
Glucose Metabolism Disorders
Metabolic Diseases
Endocrine System Diseases
Insulin, Globin Zinc
Hypoglycemic Agents
Physiological Effects of Drugs