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Type 2 DiabetesLIDNCT01977560

Diet and Exercise Intervention in Type 2 Diabetes

A study testing Intensive Lifestyle Intervention in people with Type 2 Diabetes, run by Washington University School of Medicine at 1 site in United States.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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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. Read more about this study

Who is it for?
Ages 25 to 68 years
Conditions the study is for
Type 2 Diabetes
What is being tested?
Intensive Lifestyle Intervention
Could I receive a placebo?
No, everyone receives an active treatment
How many people
18 participants
Where
1 siteUnited States
Study dates
Oct 2013to Jul 2016
Phase
Interventional
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 25 to 68 years
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • 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.

Who cannot join

  • 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
Show all 20Show fewer
  • 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.

Trial locations and contacts

1 site in 1 country.

United States1 site

  • Washington University School of Medicine

    St Louis, Missouri, 63110

Other trials in United States

About this study

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.

Read the 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).

Conditions
Type 2 Diabetes
Being tested
Intensive Lifestyle Intervention, Standard Care
Keywords
Type 2 diabetes, Exercise, Weight loss
Medical subject headings
Diabetes Mellitus, Type 2, Motor Activity, Weight Loss

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Intensive Lifestyle InterventionBehavioural

    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 CareBehavioural

    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).

Study groups in NCT01977560
Study groupRoleWhat they receive
Standard CareOtherParticipants randomized to this arm will receive dietary and physical activity instructions as recommended by the American Diabetes Association (ADA) guidelines.
Receives: Behavioral: Standard Care
Intensive Lifestyle interventionExperimentalParticipants 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.
Receives: Behavioral: Intensive Lifestyle Intervention

What is being measured

The primary outcome is the main question the study is designed to answer.

  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.

    Measured: 7-8 months

Secondary outcomes (15)

  1. Liver insulin sensitivity

    Liver insulin sensitivity will be assessed by using the hepatic insulin sensitivity index.

    Measured: 7-8 months

  2. Adipose tissue insulin sensitivity

    Adipose tissue insulin sensitivity will be assessed by using the adipose tissue insulin sensitivity index.

    Measured: 7-8 months

  3. β-cell function

    β-cell function will be assessed from a modified oral glucose tolerance test

    Measured: 7-8 months

  4. Insulin clearance

    Insulin clearance will be assessed from a modified oral glucose tolerance test

    Measured: 7-8 months

  5. Diabetes remission

    Remission of type 2 diabetes will be defined as HbA1c <6.0% without the use of diabetes medications use of diabetes medications.

    Measured: 7-8 months

  6. Cardiorespiratory fitness

    Peak oxygen consumption will be assessed using indirect calorimetry during a graded exercise test to volitional exhaustion.

    Measured: 7-8 months

  7. 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.

    Measured: 7-8 months

  8. Whole-body fat mass

    Total body fat mass will be assessed by dual-energy X-ray absorptiometry.

    Measured: 7-8 months

  9. Whole-body fat-free mass

    Fat-free mass will be assessed by dual-energy X-ray absorptiometry.

    Measured: 7-8 months

  10. Appendicular lean mass

    Appendicular lean mass will be assessed by dual-energy X-ray absorptiometry.

    Measured: 7-8 months

  11. Intra-abdominal adipose tissue volume

    Intra-abdominal adipose tissue volume will be determined by using magnetic resonance imaging.

    Measured: 7-8 months

  12. Intrahepatic triglyceride content

    Intrahepatic triglyceride content will be determined by using magnetic resonance spectroscopy.

    Measured: 7-8 months

  13. Plasma adipokine concentrations

    Plasma adiponectin and PAI-1 concentrations will be measured in the Washington University Clinical Core Laboratory.

    Measured: 7-8 months

  14. 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.

    Measured: 7-8 months

  15. Skeletal muscle mitochondrial metabolites

    The content of muscle mitochondrial-related metabolites will be determined by liquid chromatography mass spectrometry.

    Measured: 7-8 months

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted6 Nov 2013 (estimated)
  2. Study startOct 2013
  3. Primary completionJul 2016
  4. Study completionJul 2016

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase N/A
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Parallel groups
Masking
None (open label)
Enrolment
18 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT01977560
Sponsor's protocol ID
201302095
Acronym
LID
Status last verified
Apr 2022
First submitted
14 Oct 2013
Last updated
15 Apr 2022
Results posted
No
Data monitoring committee
Yes
FDA-regulated drug
No
FDA-regulated device
No

Publications

  • 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.

    PubMed 36084645

  • 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.

    PubMed 34905513

Questions about this trial

What is this clinical trial studying?

A study testing Intensive Lifestyle Intervention in people with Type 2 Diabetes, run by Washington University School of Medicine at 1 site in United States.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 5 inclusion and 20 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 15 Apr 2022. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Skeletal muscle insulin sensitivity (time frame: 7-8 months). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT01977560, which also lists 2 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 15 Apr 2022.

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