Back to resultsMitochondrial Impairment in Muscle Insulin Resistance
Primary Purpose
Diabetes, Obesity
Status
Completed
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
weight loss/ exercise
Sponsored by
About this trial
This is an interventional treatment trial for Diabetes focused on measuring Mitochondria
Eligibility Criteria
Inclusion Criteria: AGE 30 to 55 years old BMI 28 to 38 kg/m2 BLOOD PRESSURE Systolic < 150 ; Diastolic < 95 SEDENTARY Currently not engaged in a regular exercise program and a VO2 max pre-training value < 55 ml/kg-fat free mass-min HEALTH (Group 1) Type 2 diabetes mellitus for < 10 years and independent in SBGM HEALTH (Group 2) Non-diabetic with impaired glucose tolerance (as per ADA) or with Metabolic Syndrome (as per NCEP-ATP III) HEALTH Must be in good general health with no known h/o the following: liver disease, kidney disease, PVD (including diminished pulses, or H/O thrombophlebitis), heart disease (including any h/o MI), neuromuscular disease, neurological disease (including peripheral neuropathy or muscle wasting), paresis, edema , current malignancy, or any drug or alcohol abuse, LAB VALUES Enroll if: No Proteinuria (defined as < 1+ protein on routine dipstick) Hct > 34% ALT < 80, AST < 80, Alk Phos < 240 sTSH < 8 (Group 2) 2 hr glucose on OGTT >140mg/dl but < 200mg/dl or NCEP-ATP III criteria) Triglyceride < 450 Cholesterol < 300 Negative Urine Pregnancy Exclusion Criteria: (Group 1) anti-hypertensives, "statin" hypolipemics, and diabetic medications okay but exclude if taking: insulin, or a hypolipemic that is not a "statin" (Group 2) "statin" hypolipemic medications are okay. A hypolipemic that is not a "statin" will exclude. Inability and / or unwillingness to comply with the protocol as written Previous difficulty with lidocaine or other local anesthetic Claustrophobia Wt gain or loss of > 3 kg during past 4 weeks
Sites / Locations
- University of Pittsburgh
Outcomes
Primary Outcome Measures
To measure the functional capacity of mitochondria in skeletal muscle of those with T2DM and those at increased risk of developing T2DM
Secondary Outcome Measures
To assess whether exercise and diet can improve mitochondrial function and morphology.
Full Information
NCT ID
NCT00222924
First Posted
September 20, 2005
Last Updated
December 14, 2007
Sponsor
University of Pittsburgh
Collaborators
National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)
1. Study Identification
Unique Protocol Identification Number
NCT00222924
Brief Title
Mitochondrial Impairment in Muscle Insulin Resistance
Official Title
Mitochondrial Impairment in Muscle Insulin Resistance
Study Type
Interventional
2. Study Status
Record Verification Date
December 2007
Overall Recruitment Status
Completed
Study Start Date
December 2003 (undefined)
Primary Completion Date
undefined (undefined)
Study Completion Date
December 2006 (Actual)
3. Sponsor/Collaborators
Name of the Sponsor
University of Pittsburgh
Collaborators
National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)
4. Oversight
5. Study Description
Brief Summary
This investigation is being carried out to learn more about research findings from a study that was completed last year. Those findings revealed that within the skeletal muscle cells of individuals with type 2 diabetes, there was often damage to the mitochondria (the muscle cell's power source or the machinery of the muscle cell that produces energy). In individuals with type 2 diabetes, the liver continues to release sugar even when sugar levels are normal; the pancreas is not able to produce and release insulin normally; and the muscle and fat cells no longer respond as effectively to insulin. These defects lead to an abnormal rise of sugar in the blood. In this study, we want both to look more closely at the mitochondria and see if there is potential for improving mitochondrial functioning (improving the machinery of the muscle cell that produces energy) and reversing mitochondrial damage through a weight loss or a combined exercise/weight loss program. The program you get assigned to will be determined by a process called randomization (like a flip of a coin).
Detailed Description
Recent research from our laboratory has detected novel findings concerning damage to mitochondria within skeletal muscle in type 2 diabetes (type 2 DM), damage that is evident morphologically and by functional criteria. In this project, we propose, firstly, to more fully test this hypothesis of an impaired bio-energetic capacity, and to begin to examine the pathogenesis of damage to mitochondria in type 2 DM. We are also interested in assessing the potential for reversing damage, and improving functional capacity of mitochondria through a weight loss or a combined exercise and weight loss intervention.
The first specific aim is to measure the functional capacity of mitochondria in human skeletal muscle in type 2 DM and in those at apparent risk for type 2 DM (obese, sedentary, non-diabetic adults with the Metabolic Syndrome and/or impaired glucose tolerance). The second specific aim is to examine the morphology of mitochondria in human skeletal muscle in type 2 DM and in those at apparent risk for type 2 DM. The third specific aim is to examine the pathogenesis of mitochondrial damage in type 2 DM and in those at apparent risk for type 2 DM. The fourth specific aim is to assess whether exercise and diet can improve mitochondrial function and morphology in type 2 DM and in those at apparent risk for type 2 DM.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Diabetes, Obesity
Keywords
Mitochondria
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Factorial Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
49 (false)
8. Arms, Groups, and Interventions
Intervention Type
Behavioral
Intervention Name(s)
weight loss/ exercise
Primary Outcome Measure Information:
Title
To measure the functional capacity of mitochondria in skeletal muscle of those with T2DM and those at increased risk of developing T2DM
Secondary Outcome Measure Information:
Title
To assess whether exercise and diet can improve mitochondrial function and morphology.
10. Eligibility
Sex
All
Minimum Age & Unit of Time
30 Years
Maximum Age & Unit of Time
55 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
Inclusion Criteria:
AGE 30 to 55 years old BMI 28 to 38 kg/m2 BLOOD PRESSURE Systolic < 150 ; Diastolic < 95 SEDENTARY Currently not engaged in a regular exercise program and a VO2 max pre-training value < 55 ml/kg-fat free mass-min HEALTH (Group 1) Type 2 diabetes mellitus for < 10 years and independent in SBGM HEALTH (Group 2) Non-diabetic with impaired glucose tolerance (as per ADA) or with Metabolic Syndrome (as per NCEP-ATP III)
HEALTH Must be in good general health with no known h/o the following:
liver disease, kidney disease, PVD (including diminished pulses, or H/O thrombophlebitis), heart disease (including any h/o MI), neuromuscular disease, neurological disease (including peripheral neuropathy or muscle wasting), paresis, edema , current malignancy, or any drug or alcohol abuse, LAB VALUES Enroll if: No Proteinuria (defined as < 1+ protein on routine dipstick) Hct > 34% ALT < 80, AST < 80, Alk Phos < 240 sTSH < 8 (Group 2) 2 hr glucose on OGTT >140mg/dl but < 200mg/dl or NCEP-ATP III criteria) Triglyceride < 450 Cholesterol < 300 Negative Urine Pregnancy
Exclusion Criteria:
(Group 1) anti-hypertensives, "statin" hypolipemics, and diabetic medications okay but exclude if taking: insulin, or a hypolipemic that is not a "statin" (Group 2) "statin" hypolipemic medications are okay. A hypolipemic that is not a "statin" will exclude.
Inability and / or unwillingness to comply with the protocol as written Previous difficulty with lidocaine or other local anesthetic Claustrophobia Wt gain or loss of > 3 kg during past 4 weeks
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
David E. Kelley, MD
Organizational Affiliation
University of Pittsburgh
Official's Role
Principal Investigator
Facility Information:
Facility Name
University of Pittsburgh
City
Pittsburgh
State/Province
Pennsylvania
ZIP/Postal Code
15213
Country
United States
12. IPD Sharing Statement
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Mitochondrial Impairment in Muscle Insulin Resistance
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