Mitochondrial Impairment in Muscle Insulin Resistance

NCT00222924 | Completed

• 2 other identifiers: 021165R01DK049200
• Study Type: interventional
• Target: 49
• Locations: 1 country
• Sites: 1

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).

Conditions

Diabetes; Obesity

Keywords

Mitochondria

Outcome Measures

Primary Outcomes (1)

• To measure the functional capacity of mitochondria in skeletal muscle of those with T2DM and those at increased risk of developing T2DM

Secondary Outcomes (1)

• To assess whether exercise and diet can improve mitochondrial function and morphology.

Interventions

weight loss/ exercise BEHAVIORAL

Eligibility Criteria

• Age: 30 Years - 55 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• 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

You may not qualify if:

• (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

Sponsors & Collaborators

• University of Pittsburgh: lead
• National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK): collaborator

Study Sites (1)

University of Pittsburgh

Pittsburgh, Pennsylvania, 15213, United States

Location

MeSH Terms

Conditions

Diabetes Mellitus; Obesity

Interventions

Exercise

Condition Hierarchy (Ancestors)

Glucose Metabolism Disorders; Metabolic Diseases; Nutritional and Metabolic Diseases; Endocrine System Diseases; Overweight; Overnutrition; Nutrition Disorders; Body Weight; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Motor Activity; Movement; Musculoskeletal Physiological Phenomena; Musculoskeletal and Neural Physiological Phenomena

Study Officials

• David E. Kelley, MD

  University of Pittsburgh

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: FACTORIAL
• Sponsor Type: OTHER

Study Record Dates

• First Submitted: September 20, 2005
• First Posted: September 22, 2005
• Study Start: December 1, 2003
• Study Completion: December 1, 2006
• Last Updated: December 19, 2007

Record last verified: 2007-12

Locations

US (1)