Back to resultsDiet and Exercise Intervention in Type 2 Diabetes (LID)
Primary Purpose
Type 2 Diabetes
Status
Completed
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Intensive Lifestyle Intervention
Standard Care
Sponsored by
About this trial
This is an interventional treatment trial for Type 2 Diabetes focused on measuring Type 2 diabetes, Exercise, Weight loss
Eligibility Criteria
Inclusion Criteria:
- Age 25-68 yrs old
- BMI 27.0-50.0 kg/m²
- 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
- HbA1C ≤9.5 %.
- 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:
- Any change in diabetes medication in previous 3 months
- Treated with >0.5 units of insulin/kg body weight per day
- Unstable weight (>2% change during the last 2 months before entering the study)
- 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).
- Evidence of serious cardiac abnormalities during exercise stress testing that increase cardiac risk of initiating an exercise program.
- Creatinine >1.5 mg/dL
- Microalbuminuria; spot urine albumin:creatinine ratio >50 (50 μg albumin/mg creatinine)
- Coagulation disorders
- Anemia (Hemoglobin <10.0 g/dL)
- Liver enzymes (ALT and AST) ≥3 times the upper limit of normal
- Uncontrolled proliferative diabetic retinopathy
- Severe peripheral neuropathy diagnosed by monofilament testing
- Severe organ dysfunction
- Pregnant or breastfeeding
- Participating in regular exercise (>1 h of structured exercise/week)
- Joint replacement within the last year
- Smokes tobacco
- Severe lactose intolerance
- Take any medication that might interfere with interpretation of the metabolic studies
- 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.
Sites / Locations
- Washington University School of Medicine
Arms of the Study
Arm 1
Arm 2
Arm Type
Other
Experimental
Arm Label
Standard Care
Intensive Lifestyle intervention
Arm Description
Participants randomized to this arm will receive dietary and physical activity instructions as recommended by the American Diabetes Association (ADA) guidelines.
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.
Outcomes
Primary Outcome Measures
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.
Secondary Outcome Measures
Liver insulin sensitivity
Liver insulin sensitivity will be assessed by using the hepatic insulin sensitivity index.
Adipose tissue insulin sensitivity
Adipose tissue insulin sensitivity will be assessed by using the adipose tissue insulin sensitivity index.
β-cell function
β-cell function will be assessed from a modified oral glucose tolerance test
Insulin clearance
Insulin clearance will be assessed from a modified oral glucose tolerance test
Diabetes remission
Remission of type 2 diabetes will be defined as HbA1c <6.0% without the use of diabetes medications use of diabetes medications.
Cardiorespiratory fitness
Peak oxygen consumption will be assessed using indirect calorimetry during a graded exercise test to volitional exhaustion.
Muscle strength
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
Total body fat mass will be assessed by dual-energy X-ray absorptiometry.
Whole-body fat-free mass
Fat-free mass will be assessed by dual-energy X-ray absorptiometry.
Appendicular lean mass
Appendicular lean mass will be assessed by dual-energy X-ray absorptiometry.
Intra-abdominal adipose tissue volume
Intra-abdominal adipose tissue volume will be determined by using magnetic resonance imaging.
Intrahepatic triglyceride content
Intrahepatic triglyceride content will be determined by using magnetic resonance spectroscopy.
Plasma adipokine concentrations
Plasma adiponectin and PAI-1 concentrations will be measured in the Washington University Clinical Core Laboratory.
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.
Skeletal muscle mitochondrial metabolites
The content of muscle mitochondrial-related metabolites will be determined by liquid chromatography mass spectrometry.
Full Information
NCT ID
NCT01977560
First Posted
October 14, 2013
Last Updated
April 13, 2022
Sponsor
Washington University School of Medicine
Collaborators
National Dairy Council, American Egg Board
1. Study Identification
Unique Protocol Identification Number
NCT01977560
Brief Title
Diet and Exercise Intervention in Type 2 Diabetes
Acronym
LID
Official Title
Diet and Exercise Intervention in Type 2 Diabetes
Study Type
Interventional
2. Study Status
Record Verification Date
April 2022
Overall Recruitment Status
Completed
Study Start Date
October 2013 (Actual)
Primary Completion Date
July 2016 (Actual)
Study Completion Date
July 2016 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Washington University School of Medicine
Collaborators
National Dairy Council, American Egg Board
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
Yes
5. Study Description
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).
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Type 2 Diabetes
Keywords
Type 2 diabetes, Exercise, Weight loss
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
18 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Standard Care
Arm Type
Other
Arm Description
Participants randomized to this arm will receive dietary and physical activity instructions as recommended by the American Diabetes Association (ADA) guidelines.
Arm Title
Intensive Lifestyle intervention
Arm Type
Experimental
Arm Description
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.
Intervention Type
Behavioral
Intervention Name(s)
Intensive Lifestyle Intervention
Intervention Description
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.
Intervention Type
Behavioral
Intervention Name(s)
Standard Care
Intervention Description
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).
Primary Outcome Measure Information:
Title
Skeletal muscle insulin sensitivity
Description
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
Secondary Outcome Measure Information:
Title
Liver insulin sensitivity
Description
Liver insulin sensitivity will be assessed by using the hepatic insulin sensitivity index.
Time Frame
7-8 months
Title
Adipose tissue insulin sensitivity
Description
Adipose tissue insulin sensitivity will be assessed by using the adipose tissue insulin sensitivity index.
Time Frame
7-8 months
Title
β-cell function
Description
β-cell function will be assessed from a modified oral glucose tolerance test
Time Frame
7-8 months
Title
Insulin clearance
Description
Insulin clearance will be assessed from a modified oral glucose tolerance test
Time Frame
7-8 months
Title
Diabetes remission
Description
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
Title
Cardiorespiratory fitness
Description
Peak oxygen consumption will be assessed using indirect calorimetry during a graded exercise test to volitional exhaustion.
Time Frame
7-8 months
Title
Muscle strength
Description
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
Title
Whole-body fat mass
Description
Total body fat mass will be assessed by dual-energy X-ray absorptiometry.
Time Frame
7-8 months
Title
Whole-body fat-free mass
Description
Fat-free mass will be assessed by dual-energy X-ray absorptiometry.
Time Frame
7-8 months
Title
Appendicular lean mass
Description
Appendicular lean mass will be assessed by dual-energy X-ray absorptiometry.
Time Frame
7-8 months
Title
Intra-abdominal adipose tissue volume
Description
Intra-abdominal adipose tissue volume will be determined by using magnetic resonance imaging.
Time Frame
7-8 months
Title
Intrahepatic triglyceride content
Description
Intrahepatic triglyceride content will be determined by using magnetic resonance spectroscopy.
Time Frame
7-8 months
Title
Plasma adipokine concentrations
Description
Plasma adiponectin and PAI-1 concentrations will be measured in the Washington University Clinical Core Laboratory.
Time Frame
7-8 months
Title
Transcriptome in muscle and adipose tissue
Description
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
Title
Skeletal muscle mitochondrial metabolites
Description
The content of muscle mitochondrial-related metabolites will be determined by liquid chromatography mass spectrometry.
Time Frame
7-8 months
10. Eligibility
Sex
All
Minimum Age & Unit of Time
25 Years
Maximum Age & Unit of Time
68 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
Age 25-68 yrs old
BMI 27.0-50.0 kg/m²
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
HbA1C ≤9.5 %.
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:
Any change in diabetes medication in previous 3 months
Treated with >0.5 units of insulin/kg body weight per day
Unstable weight (>2% change during the last 2 months before entering the study)
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).
Evidence of serious cardiac abnormalities during exercise stress testing that increase cardiac risk of initiating an exercise program.
Creatinine >1.5 mg/dL
Microalbuminuria; spot urine albumin:creatinine ratio >50 (50 μg albumin/mg creatinine)
Coagulation disorders
Anemia (Hemoglobin <10.0 g/dL)
Liver enzymes (ALT and AST) ≥3 times the upper limit of normal
Uncontrolled proliferative diabetic retinopathy
Severe peripheral neuropathy diagnosed by monofilament testing
Severe organ dysfunction
Pregnant or breastfeeding
Participating in regular exercise (>1 h of structured exercise/week)
Joint replacement within the last year
Smokes tobacco
Severe lactose intolerance
Take any medication that might interfere with interpretation of the metabolic studies
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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Samuel Klein, MD
Organizational Affiliation
Washington University School of Medicine
Official's Role
Principal Investigator
Facility Information:
Facility Name
Washington University School of Medicine
City
Saint Louis
State/Province
Missouri
ZIP/Postal Code
63110
Country
United States
12. IPD Sharing Statement
Citations:
PubMed Identifier
36084645
Citation
Yoshino M, Yoshino J, Smith GI, Stein RI, Bittel AJ, Bittel DC, Reeds DN, Sinacore DR, Cade WT, Patterson BW, Cho K, Patti GJ, Mittendorfer B, Klein S. Worksite-based intensive lifestyle therapy has profound cardiometabolic benefits in people with obesity and type 2 diabetes. Cell Metab. 2022 Oct 4;34(10):1431-1441.e5. doi: 10.1016/j.cmet.2022.08.012. Epub 2022 Sep 8.
Results Reference
derived
PubMed Identifier
34905513
Citation
Mittendorfer B, Patterson BW, Smith GI, Yoshino M, Klein S. beta Cell function and plasma insulin clearance in people with obesity and different glycemic status. J Clin Invest. 2022 Feb 1;132(3):e154068. doi: 10.1172/JCI154068.
Results Reference
derived
Learn more about this trial
Diet and Exercise Intervention in Type 2 Diabetes
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