Optimizing Body Composition for Function in Older Adults
Condition: Obesity; Overweight With Indications for Weight Loss
MeSH terms: Overweight; Weight Loss
Study type: Interventional
Phase: Phase 4

Summary: 
      The purpose of this pilot study is to compare two strategies intended to improve the health
      of overweight older adults by improving body composition. One strategy, resistance training,
      is designed to preserve skeletal muscle mass. The other strategy, the use of a PPAR-γ
      agonist, is designed to enhance the loss of fat from visceral and skeletal depots. These
      strategies will be used in conjunction with a hypocaloric diet and will be compared to a
      hypocaloric diet alone to determine if either of these strategies are superior in reducing
      visceral fat and preserving muscle mass.
    

Detailed description: 
      In this pilot we propose to recruit 88 older (65 - 79 yrs) men (n=48) and women (n=40) at
      risk for disability and with indications for weight loss according to NIH guidelines. All
      will be enrolled in a dietary intervention designed to generate a caloric deficit of 500
      kcal/day for a 4 month period. All will receive supplemental vitamin D and calcium. These
      participants will be randomized into one of 4 groups:

      Group 1 - Hypocaloric diet (and placebo) Group 2 - Hypocaloric diet and resistance training
      designed to maximize muscular power (and placebo) Group 3 - Hypocaloric diet and a PPAR- γ
      agonist (pioglitazone/Actos™) Group 4 - Hypocaloric diet and resistance training and
      pioglitazone/Actos™

      The specific aims of the pilot are:

        1. In both men and women, to determine whether randomization to resistance exercise is
           associated with an increased retention of appendicular non-bone lean mass compared to
           those not undergoing power training.

        2. In both men and women, to determine whether randomization to the pioglitazone group is
           associated with an increased loss of visceral adiposity relative to randomization to the
           non-pioglitazone group.

        3. Assess the feasibility of the recruitment, assessment and intervention strategies

        4. To estimate adherence to the weight loss, exercise training, and drug interventions;

        5. In this population, to determine measurement characteristics of the functional outcomes
           that will be considered as primary end-points of the larger study.

        6. To obtain pilot data on a subset of participants to determine the feasibility,
           acceptability and measurement characteristics of muscle samples (biopsies) to quantify
           intramyocellular lipid in this study population.
    

Intervention name(s): Pioglitazone; Resistance exercise training to maximize muscle power; Hypocaloric diet; Placebo
Intervention type(s): Drug; Behavioral; Behavioral; Drug
Intervention MeSH terms: Pioglitazone
Allocation: Randomized
Intervention model: Factorial Assignment
Masking: Single (Participant)
Primary purpose: Treatment
Keywords: Body Composition; Sarcopenia; Weight loss trials; Intervention studies; Elderly