Lifestyle and Glucose Lowering Medication in T2DM

December 12, 2018 updated by: Mathias Ried-Larsen, Rigshospitalet, Denmark

Does Intensive Life Style Intervention Reduce the Need for Glucose Lowering Medications in Patients With Type 2 Diabetes? The U-TURN Project

This study evaluates the effect of a lifestyle intervention maintenance of glycemic control while reducing glucose lowering drugs in patients with type 2 diabetes mellitus. The intervention group receives an intensive lifestyle intervention including exercise and diet lifestyle modifications. The reference group receives diabetes educational advice. Both groups will have their pharmacological treatment regulated across the study. The primary hypothesis is that lifestyle change is sufficient to maintain glycemic control while decreasing the anti-diabetic medication in a sample patients with type 2 diabetes mellitus.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Detailed Description

Adherence to lifestyle modifications including increased exercise and healthy diet improves glycemic control in patients with type 2 diabetes mellitus. However, few have investigated the combined effects of these lifestyle changes on maintenance of glycemic control while decreasing the usage of anti-diabetic medications.

The primary hypothesis is that lifestyle change is equivalent in maintaining glycemic control (Hba1c) compared to the standard pharmacological treatment,

The U-TURN trial also tests the effects on one key secondary outcome (glucose lowering medication) and examines the effects on sleep quality, fatigue sleepiness, sleep pattern, cardio vascular disease risk factors, psychological outcomes, blood pressure and cholesterol lowering medication. The participants (N=120) is randomized into a experimental group (N=80) and a standard care group (N=40).

Additionally, the effects of the study will be evaluated 24 month post randomization.

Study Type

Interventional

Enrollment (Anticipated)

97

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Denmark
      • Copenhagen, Denmark, 2100
        • Center for Physical Activity Research, Copenhagen University Hospital

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (ADULT, OLDER_ADULT)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • Less than three anti-diabetic medications.
  • Diabetes 2 duration of max 10 years
  • BMI >25 but <40 kg/m2,
  • Accept of medical regulation by the UTURN endocrinologists only
  • Accept of purchasing a fitness club membership through U-TURN collaborator

Exclusion Criteria:

  • Hba1c> 9% (75 mmol/mol)
  • Insulin usage
  • Presence of one or more of the following micro- and macrovascular complications of T2DM; a.Diabetic retinopathy (except mild nonproliferative retinopathy or early proliferative retinopathy) b. Macro-albuminuria or nephropathy c. Diabetic neuropathy (except mild affected vibratory testing (<50 Volt)) d. Arterial insufficiency e. Ischemic heart disease
  • Steroid treatment (inhalation) until three months before the medical examination
  • TSH raised/below the normal range
  • Liver disease (ALAT/ASAT thrice normal range)
  • Inability or contraindication to increased levels of physical activity (Pedersen BK and Saltin B)
  • Evidence of anaemia
  • Lung disease (except mild asthma and mild chronic obstructive pulmonary disease)
  • Heart disease
  • Kidney disease (creatinine above 130 µM or macro albuminuria)
  • Pregnancy

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: TREATMENT
  • Allocation: RANDOMIZED
  • Interventional Model: PARALLEL
  • Masking: SINGLE

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
EXPERIMENTAL: U-TURN intervention

The intervention group will receive an intensive lifestyle intervention including partly supervised aerobic and strength exercise, diet plans and counseling by clinical dietitians. All exercise will be supervised initially and the supervision will be reduced gradually across the 12-month intervention. Additionally, the participants will be offered educational classes on implementation of a healthy lifestyle and diabetes education and support by trained nurses.

Participants in this group will have their pharmacological treatment regulated by the study endocrinologists using a standardized pharmacological treatment. The treatment is in accordance with the Danish guidelines.
Behavioral: U-TURN
Participants in this group will receive individual and group based interventions on obtaining and maintaining a healthy lifestyle, while having the pharmacological treatment regulated
ACTIVE_COMPARATOR: Standard care

The reference group will receive diabetes education and support by trained nurses.

Participants in this group will have their pharmacological treatment regulated by the study endocrinologists using a standardized pharmacological treatment. The treatment is in accordance with the Danish guidelines.
Behavioral: Standard care
Standard individual diabetes support

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Change in Hba1c
Time Frame: 0, 3, 6, 9, 12 months
blood sampling of Hba1c
0, 3, 6, 9, 12 months

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Change in glucose lowering medication
Time Frame: 0, 3, 6, 9, 12 months
Change in doses of Metformin, GLP-1 analog, insulin. The change will be evaluate according to changes on the pre-specified regulation algorithm.
0, 3, 6, 9, 12 months

Other Outcome Measures

Outcome Measure
Measure Description
Time Frame
incidence of hypo-glycemic episodes
Time Frame: 0, 3, 6, 9, 12, 24 months
Self-report to study nurse
0, 3, 6, 9, 12, 24 months
Changes Ldl cholesterol
Time Frame: 0, 3, 6, 9, 12, 24 months
Blod sampling
0, 3, 6, 9, 12, 24 months
Changes Hdl cholesterol
Time Frame: 0, 3, 6, 9, 12, 24 months
Blood sampling
0, 3, 6, 9, 12, 24 months
Changes total cholesterol
Time Frame: 0, 3, 6, 9, 12, 24 months
Blood sampling
0, 3, 6, 9, 12, 24 months
Changes in triglycerides
Time Frame: 0, 3, 6, 9, 12, 24 months
Blood sampling
0, 3, 6, 9, 12, 24 months
Changes in bdnf-a
Time Frame: 0, 12 months
Blood sampling
0, 12 months
Change in physical fitness
Time Frame: 0, 12, 24 months
Progressive treadmill protocol
0, 12, 24 months
Change in body composition (DXA scan)
Time Frame: 0, 3, 6, 9, 12, 24 months
DXA scan
0, 3, 6, 9, 12, 24 months
Change in sleep quality
Time Frame: 0, 12, months
Self-report using the PSQI questionnaire
0, 12, months
Change in sleepiness
Time Frame: 0, 12, months
Self-report using the Epsworth questionnaire
0, 12, months
Change in sleep pattern
Time Frame: 0, 12, months
Cardio-respiratory monitoring
0, 12, months
Change in the degree of depression
Time Frame: 0, 12, 24 months
Self-report using the BDI-II questionnaire
0, 12, 24 months
Change in Glucose tolerance (2-h oral glucose tolerance test)
Time Frame: 0, 12, 24 months
2-h oral glucose tolerance test
0, 12, 24 months
Change in Well-being
Time Frame: 0, 12, 24 months
Self-report using the questionnaire SF-36 and MFI20
0, 12, 24 months
Change in motivation for exercise
Time Frame: 0, 12, 24 months
Self-report using the questionnaire BREQ-2
0, 12, 24 months
Change in cognitive function
Time Frame: 0, 12 months
Self-report using the CANTAB test battery
0, 12 months
Change in arterial function
Time Frame: 0, 12 months
Arterial function will be determined using flow mediated dilation in a sub set of N=20 patients in each intervention arm (Total N=20)
0, 12 months
Partial T2D remission
Time Frame: 24 months
No active glucose lowering medication and HbA1c<48 mmol/mol and Fasting blood glucose<6,9 mmol/l
24 months
Full T2D remission
Time Frame: 24 months
No active glucose lowering medication and HbA1c<39 mmol/mol and Fasting blood glucose<5.6 mmol/l
24 months
Change in low grade inflammation
Time Frame: 0, 12, 24 months
The change in pro- and anti inflammatory markers will be evaluated
0, 12, 24 months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Rigshospitalet, Denmark

Collaborators

TRYG Foundation

Investigators

  • Principal Investigator: Mathias Ried-Larsen, PhD, Rigshospitalet, Denmark

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (ACTUAL)

April 1, 2015

Primary Completion (ACTUAL)

September 1, 2017

Study Completion (ACTUAL)

September 1, 2017

Study Registration Dates

First Submitted

April 6, 2015

First Submitted That Met QC Criteria

April 10, 2015

First Posted (ESTIMATE)

April 15, 2015

Study Record Updates

Last Update Posted (ACTUAL)

December 13, 2018

Last Update Submitted That Met QC Criteria

December 12, 2018

Last Verified

December 1, 2018

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • U-TURN

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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