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

This study has been completed.
Sponsor:
Information provided by:
University of New Mexico
ClinicalTrials.gov Identifier:
NCT00508599
First received: July 26, 2007
Last updated: April 22, 2008
Last verified: April 2008
History of Changes
  Purpose

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 Intervention
Type 2 Diabetes
Insulin Resistance
 Other: Study 2 (48 hours of complete bed rest)

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Crossover Assignment
Masking: 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

Resource links provided by NLM:

U.S. FDA Resources

Further study details as provided by University of New Mexico:

Primary Outcome Measures:
  • Insulin resistance and orthostatic response [ Time Frame: 48 hours bed rest and 48 hours activity ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Change in glucose, insulin, and orthostatic impairment. [ Time Frame: 48 hours of bed rest and 48 hours of Activity ] [ Designated as safety issue: No ]

Enrollment: 16
Study Start Date: May 2003
Study Completion Date: February 2006
Primary Completion Date: October 2004 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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.

  Show Detailed Description

  Eligibility

Ages Eligible for Study:   21 Years to 75 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   Yes
Criteria

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
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00508599

Locations
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
Investigators
Principal Investigator: David S Schade, M.D. University of New Mexico
  More Information

Publications:

Additional publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):

Responsible Party: David S. Schade, M.D., University of New Mexico
ClinicalTrials.gov Identifier: NCT00508599     History of Changes
Other Study ID Numbers: 03-163
Study First Received: July 26, 2007
Last Updated: April 22, 2008
Health Authority: United States: Institutional Review Board

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

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

ClinicalTrials.gov processed this record on June 17, 2013