Type 2 Diabetes
Conditions
Keywords
Type 2 diabetes, Exercise, Weight loss
Brief summary
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.
Detailed description
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).
Interventions
BEHAVIORALIntensive Lifestyle Intervention
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.
BEHAVIORALStandard Care
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).
Sponsors
National Dairy Council
American Egg Board
Washington University School of Medicine
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
25 Years to 68 Years
Healthy volunteers
No
Inclusion criteria
1. Age 25-68 yrs old 2. BMI 27.0-50.0 kg/m² 3. Diagnosis of type 2 diabetes based on HbA1C\>6.5% or results of an oral glucose tolerance test or current use of anti-diabetic medications 4. HbA1C ≤9.5 %. 5. Work at Washington University in St. Louis, Barnes Jewish Hospital, St. Louis Children's Hospital, Shriners, St. Louis College of Pharmacy, Central Institute for the Deaf, Rehabilitation Institute of St. Louis, and/or any institutions affiliated with these.
Exclusion criteria
1. Any change in diabetes medication in previous 3 months 2. Treated with \>0.5 units of insulin/kg body weight per day 3. Unstable weight (\>2% change during the last 2 months before entering the study) 4. History or evidence of serious pulmonary or cardiovascular disease, including acute coronary syndrome, heart failure requiring medications, or New York Heart Association class III heart failure (patients with marked limitation of activity and who are comfortable only at rest) or IV heart failure (patients who should be at complete rest, confined to bed or chair and who have discomfort with any physical activity). 5. Evidence of serious cardiac abnormalities during exercise stress testing that increase cardiac risk of initiating an exercise program. 6. Creatinine \>1.5 mg/dL 7. Microalbuminuria; spot urine albumin:creatinine ratio \>50 (50 μg albumin/mg creatinine) 8. Coagulation disorders 9. Anemia (Hemoglobin \<10.0 g/dL) 10. Liver enzymes (ALT and AST) ≥3 times the upper limit of normal 11. Uncontrolled proliferative diabetic retinopathy 12. Severe peripheral neuropathy diagnosed by monofilament testing 13. Severe organ dysfunction 14. Pregnant or breastfeeding 15. Participating in regular exercise (\>1 h of structured exercise/week) 16. Joint replacement within the last year 17. Smokes tobacco 18. Severe lactose intolerance 19. Take any medication that might interfere with interpretation of the metabolic studies 20. Unable or unwilling to follow the study protocol or for any reason the research team believes the volunteer is not an appropriate candidate for this study, including non-compliance with screening appointments or previous medical visits.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Skeletal muscle insulin sensitivity | 7-8 months | 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. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Adipose tissue insulin sensitivity | 7-8 months | Adipose tissue insulin sensitivity will be assessed by using the adipose tissue insulin sensitivity index. |
| β-cell function | 7-8 months | β-cell function will be assessed from a modified oral glucose tolerance test |
| Insulin clearance | 7-8 months | Insulin clearance will be assessed from a modified oral glucose tolerance test |
| Diabetes remission | 7-8 months | Remission of type 2 diabetes will be defined as HbA1c \<6.0% without the use of diabetes medications use of diabetes medications. |
| Cardiorespiratory fitness | 7-8 months | Peak oxygen consumption will be assessed using indirect calorimetry during a graded exercise test to volitional exhaustion. |
| Muscle strength | 7-8 months | 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. |
| Whole-body fat mass | 7-8 months | Total body fat mass will be assessed by dual-energy X-ray absorptiometry. |
| Liver insulin sensitivity | 7-8 months | Liver insulin sensitivity will be assessed by using the hepatic insulin sensitivity index. |
| Appendicular lean mass | 7-8 months | Appendicular lean mass will be assessed by dual-energy X-ray absorptiometry. |
| Intra-abdominal adipose tissue volume | 7-8 months | Intra-abdominal adipose tissue volume will be determined by using magnetic resonance imaging. |
| Intrahepatic triglyceride content | 7-8 months | Intrahepatic triglyceride content will be determined by using magnetic resonance spectroscopy. |
| Plasma adipokine concentrations | 7-8 months | Plasma adiponectin and PAI-1 concentrations will be measured in the Washington University Clinical Core Laboratory. |
| Transcriptome in muscle and adipose tissue | 7-8 months | The transcriptome (all RNA that are responsible for making proteins from DNA templates) will be evaluated by using RNA sequencing techniques. |
| Skeletal muscle mitochondrial metabolites | 7-8 months | The content of muscle mitochondrial-related metabolites will be determined by liquid chromatography mass spectrometry. |
| Whole-body fat-free mass | 7-8 months | Fat-free mass will be assessed by dual-energy X-ray absorptiometry. |
Countries
United States
Outcome results
None listed