The Effects of Two Days of Bedrest on Insulin Resistance in Type 2 Diabetics - Full Text View

Sponsor:	University of New Mexico
Information provided by:	University of New Mexico
ClinicalTrials.gov Identifier:	NCT00508599

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:

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.

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:

Genetics Home Reference related topics: 6q24-related transient neonatal diabetes mellitus

MedlinePlus related topics: Diabetes Diabetes Medicines Diabetes Type 2

Drug Information available for: Insulin Insulin beef

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.

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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:

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.

Nichiporuk 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.

Stuart 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.

Yanagibori 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.

Blanc 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.

Mikines 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. 1991 Mar;70(3):1245-54.

Yanagibori 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.

Valek 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.

Gough 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.

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

Schneider 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-Apr;15(2):104-10.

Duran-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.

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 February 12, 2012