Diet and Exercise Intervention in Type 2 Diabetes

NCT01977560 | Completed DMC

• 1 other identifier: 201302095
• Study Type: interventional
• Target: 18
• Locations: 1 country
• Sites: 1

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.

Conditions

Type 2 Diabetes

Keywords

Type 2 diabetes; Exercise; Weight loss

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (15)

• Liver insulin sensitivity

  7-8 months

• Adipose tissue insulin sensitivity

  7-8 months

• β-cell function

  7-8 months

• Insulin clearance

  7-8 months

• Diabetes remission

  7-8 months

Study Arms (2)

Standard Care

OTHER

Participants randomized to this arm will receive dietary and physical activity instructions as recommended by the American Diabetes Association (ADA) guidelines.

Behavioral: Standard Care

Intensive Lifestyle intervention

EXPERIMENTAL

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.

Behavioral: Intensive Lifestyle Intervention

Interventions

Intensive Lifestyle Intervention BEHAVIORAL

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.

Intensive Lifestyle intervention

Standard Care BEHAVIORAL

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).

Standard Care

Eligibility Criteria

• Age: 25 Years - 68 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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)

Sponsors & Collaborators

• Washington University School of Medicine: lead
• National Dairy Council: collaborator
• American Egg Board: collaborator

Study Sites (1)

Washington University School of Medicine

St Louis, Missouri, 63110, United States

Location

Related Publications (2)

• 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.

  PMID: 36084645 DERIVED

• 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.

  PMID: 34905513 DERIVED

MeSH Terms

Conditions

Diabetes Mellitus, Type 2; Motor Activity; Weight Loss

Interventions

Standard of Care

Condition Hierarchy (Ancestors)

Diabetes Mellitus; Glucose Metabolism Disorders; Metabolic Diseases; Nutritional and Metabolic Diseases; Endocrine System Diseases; Behavior; Body Weight Changes; Body Weight; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Quality Indicators, Health Care; Quality of Health Care; Health Services Administration; Health Care Quality, Access, and Evaluation

Study Officials

• Samuel Klein, MD

  Washington University School of Medicine

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: October 14, 2013
• First Posted: November 6, 2013
• Study Start: October 1, 2013
• Primary Completion: July 1, 2016
• Study Completion: July 1, 2016
• Last Updated: April 15, 2022

Record last verified: 2022-04

Locations

US (1)