Diet and Exercise Intervention in Type 2 Diabetes

Not Applicable

Completed

• Conditions: Type 2 Diabetes
• Interventions: Behavioral: Standard Care; Behavioral: Intensive Lifestyle Intervention

• Registration Number: NCT01977560
• Lead Sponsor: Washington University School of Medicine

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).

Study Timeline

• Study Start: 2013-10
• Study First Submitted: 2013-10-14
• Study First Submitted QC: 2013-10-30
• Study First Posted: 2013-11-06
• Primary Completion: 2016-07
• Study Completion: 2016-07
• Status Verified: 2022-04
• Last Update Submitted: 2022-04-13
• Last Update Posted: 2022-04-15

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 18

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.

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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.

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Standard Care	Standard Care	Participants randomized to this arm will receive dietary and physical activity instructions as recommended by the American Diabetes Association (ADA) guidelines.
Intensive Lifestyle intervention	Intensive Lifestyle Intervention	Participants randomized to this arm will be participate in weekly dietary and behavioral education session in addition to four 60-min supervised exercise training sessions per week for 8 months. All dietary and- behavioral education and exercise training sessions will be conducted at the worksite.

Primary Outcome Measures

Name	Time	Method
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 Outcome Measures

Name	Time	Method
β-cell function	7-8 months	β-cell function 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.
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.
Skeletal muscle mitochondrial metabolites	7-8 months	The content of muscle mitochondrial-related metabolites will be determined by liquid chromatography mass spectrometry.
Liver insulin sensitivity	7-8 months	Liver insulin sensitivity will be assessed by using the hepatic insulin sensitivity index.
Adipose tissue insulin sensitivity	7-8 months	Adipose tissue insulin sensitivity will be assessed by using the adipose tissue insulin sensitivity index.
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.
Intrahepatic triglyceride content	7-8 months	Intrahepatic triglyceride content will be determined by using magnetic resonance spectroscopy.
Insulin clearance	7-8 months	Insulin clearance will be assessed from a modified oral glucose tolerance test
Cardiorespiratory fitness	7-8 months	Peak oxygen consumption will be assessed using indirect calorimetry during a graded exercise test to volitional exhaustion.
Whole-body fat-free mass	7-8 months	Fat-free mass will be assessed by dual-energy X-ray absorptiometry.
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.
Plasma adipokine concentrations	7-8 months	Plasma adiponectin and PAI-1 concentrations will be measured in the Washington University Clinical Core Laboratory.

Trial Locations

Locations (1)

Washington University School of Medicine; 🇺🇸 Saint Louis, Missouri, United States