The purpose of this study is to determine the effect of a worksite-based intensive lifestyle therapy intervention (weight loss with exercise training) on blood sugar control in people with obesity and type 2 diabetics.
The purpose of this study is to conduct a randomized, controlled trial in people with obesity and type 2 diabetes to determine the therapeutic effects of intensive lifestyle therapy conducted at the worksite compared to standard care on: i) the major factors involved in the pathogenesis of type 2 diabetes (insulin sensitivity, β-cell function and the metabolic response to glucose ingestion), ii) body composition; iii) physical function (cardiorespiratory fitness and muscle strength); iv) and the potential cellular mechanisms that can affect insulin action in muscle and adipose tissue (fat).
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Enrollment
18
Participants will be instructed to consume \~500 kcal/day less than their calculated estimated total daily energy requirements. The supervised exercise program will include both endurance and resistance exercise training sessions. The doses of diabetes medications will be adjusted by study physicians every 1-2 weeks, as needed to avoid hypoglycemia.
After receiving dietary and physical activity instructions as recommended by the American Diabetes Association (ADA) guidelines participants will meet approximately every month for about 7 months with a study team member to record body weight, review diet and physical activity behaviors, and document medication use. Participants will continue their routine medical management, including regular clinic visits with their personal physician and/or diabetes educator during their participation in this study. Any changes medications will made by the participants' personal physician(s).
Washington University School of Medicine
St Louis, Missouri, United States
Skeletal muscle insulin sensitivity
Skeletal muscle insulin sensitivity will be calculated as the glucose disposal rate per kg fat-free mass divided by plasma insulin during a hyperinsulinemic-euglycemic clamp procedure.
Time frame: 7-8 months
Liver insulin sensitivity
Liver insulin sensitivity will be assessed by using the hepatic insulin sensitivity index.
Time frame: 7-8 months
Adipose tissue insulin sensitivity
Adipose tissue insulin sensitivity will be assessed by using the adipose tissue insulin sensitivity index.
Time frame: 7-8 months
β-cell function
β-cell function will be assessed from a modified oral glucose tolerance test
Time frame: 7-8 months
Insulin clearance
Insulin clearance will be assessed from a modified oral glucose tolerance test
Time frame: 7-8 months
Diabetes remission
Remission of type 2 diabetes will be defined as HbA1c \<6.0% without the use of diabetes medications use of diabetes medications.
Time frame: 7-8 months
Cardiorespiratory fitness
Peak oxygen consumption will be assessed using indirect calorimetry during a graded exercise test to volitional exhaustion.
Time frame: 7-8 months
Muscle strength
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Muscle strength will be assessed as the total maximal weight lifted during the 1 repetition maximum tests for leg press, knee flexion, seated row, and chest press exercises.
Time frame: 7-8 months
Whole-body fat mass
Total body fat mass will be assessed by dual-energy X-ray absorptiometry.
Time frame: 7-8 months
Whole-body fat-free mass
Fat-free mass will be assessed by dual-energy X-ray absorptiometry.
Time frame: 7-8 months
Appendicular lean mass
Appendicular lean mass will be assessed by dual-energy X-ray absorptiometry.
Time frame: 7-8 months
Intra-abdominal adipose tissue volume
Intra-abdominal adipose tissue volume will be determined by using magnetic resonance imaging.
Time frame: 7-8 months
Intrahepatic triglyceride content
Intrahepatic triglyceride content will be determined by using magnetic resonance spectroscopy.
Time frame: 7-8 months
Plasma adipokine concentrations
Plasma adiponectin and PAI-1 concentrations will be measured in the Washington University Clinical Core Laboratory.
Time frame: 7-8 months
Transcriptome in muscle and adipose tissue
The transcriptome (all RNA that are responsible for making proteins from DNA templates) will be evaluated by using RNA sequencing techniques.
Time frame: 7-8 months
Skeletal muscle mitochondrial metabolites
The content of muscle mitochondrial-related metabolites will be determined by liquid chromatography mass spectrometry.
Time frame: 7-8 months