Diet and Exercise Intervention in Type 2 Diabetes

Type 2 Diabetes Clinical Trial

— LID  

Official title:

Diet and Exercise Intervention in Type 2 Diabetes

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01977560
• Other study ID #: 201302095
• Status: Completed
• Phase: N/A
• Start date: October 2013
• Est. completion date: July 2016

Study information

• Verified date: April 2022
• Source: Washington University School of Medicine
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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).

Recruitment information / eligibility

• Status: Completed
• Enrollment: 18
• Est. completion date: July 2016
• Est. primary completion date: July 2016
• Accepts healthy volunteers: No
• Gender: All
• Age group: 25 Years to 68 Years

Eligibility

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.

Related Conditions & MeSH terms

• Diabetes Mellitus
• Diabetes Mellitus, Type 2
• Type 2 Diabetes

Intervention

Behavioral:
• Intensive 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.
• Standard 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).

Locations

Country	Name	City	State
United States	Washington University School of Medicine	Saint Louis	Missouri

Sponsors (3)

Lead Sponsor	Collaborator
Washington University School of Medicine	American Egg Board, National Dairy Council

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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.	7-8 months
Secondary	Liver insulin sensitivity	Liver insulin sensitivity will be assessed by using the hepatic insulin sensitivity index.	7-8 months
Secondary	Adipose tissue insulin sensitivity	Adipose tissue insulin sensitivity will be assessed by using the adipose tissue insulin sensitivity index.	7-8 months
Secondary	ß-cell function	ß-cell function will be assessed from a modified oral glucose tolerance test	7-8 months
Secondary	Insulin clearance	Insulin clearance will be assessed from a modified oral glucose tolerance test	7-8 months
Secondary	Diabetes remission	Remission of type 2 diabetes will be defined as HbA1c <6.0% without the use of diabetes medications use of diabetes medications.	7-8 months
Secondary	Cardiorespiratory fitness	Peak oxygen consumption will be assessed using indirect calorimetry during a graded exercise test to volitional exhaustion.	7-8 months
Secondary	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.	7-8 months
Secondary	Whole-body fat mass	Total body fat mass will be assessed by dual-energy X-ray absorptiometry.	7-8 months
Secondary	Whole-body fat-free mass	Fat-free mass will be assessed by dual-energy X-ray absorptiometry.	7-8 months
Secondary	Appendicular lean mass	Appendicular lean mass will be assessed by dual-energy X-ray absorptiometry.	7-8 months
Secondary	Intra-abdominal adipose tissue volume	Intra-abdominal adipose tissue volume will be determined by using magnetic resonance imaging.	7-8 months
Secondary	Intrahepatic triglyceride content	Intrahepatic triglyceride content will be determined by using magnetic resonance spectroscopy.	7-8 months
Secondary	Plasma adipokine concentrations	Plasma adiponectin and PAI-1 concentrations will be measured in the Washington University Clinical Core Laboratory.	7-8 months
Secondary	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.	7-8 months
Secondary	Skeletal muscle mitochondrial metabolites	The content of muscle mitochondrial-related metabolites will be determined by liquid chromatography mass spectrometry.	7-8 months