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
  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:


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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

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

ClinicalTrials.gov processed this record on September 16, 2014