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Lifestyle and Glucose Lowering Medication in T2DM

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ClinicalTrials.gov Identifier: NCT02417012
Recruitment Status : Completed
First Posted : April 15, 2015
Last Update Posted : December 13, 2018
Sponsor:
Collaborator:
TRYG Foundation
Information provided by (Responsible Party):
Mathias Ried-Larsen, Rigshospitalet, Denmark

Brief Summary:
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.

Condition or disease Intervention/treatment Phase
Diabetes Mellitus, Type 2 Behavioral: U-TURN Behavioral: Standard care Not Applicable

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.


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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 97 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single (Outcomes Assessor)
Primary Purpose: Treatment
Official Title: Does Intensive Life Style Intervention Reduce the Need for Glucose Lowering Medications in Patients With Type 2 Diabetes? The U-TURN Project
Actual Study Start Date : April 2015
Actual Primary Completion Date : September 2017
Actual Study Completion Date : September 2017

Resource links provided by the National Library of Medicine


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




Primary Outcome Measures :
  1. Change in Hba1c [ Time Frame: 0, 3, 6, 9, 12 months ]
    blood sampling of Hba1c


Secondary Outcome Measures :
  1. 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.


Other Outcome Measures:
  1. incidence of hypo-glycemic episodes [ Time Frame: 0, 3, 6, 9, 12, 24 months ]
    Self-report to study nurse

  2. Changes Ldl cholesterol [ Time Frame: 0, 3, 6, 9, 12, 24 months ]
    Blod sampling

  3. Changes Hdl cholesterol [ Time Frame: 0, 3, 6, 9, 12, 24 months ]
    Blood sampling

  4. Changes total cholesterol [ Time Frame: 0, 3, 6, 9, 12, 24 months ]
    Blood sampling

  5. Changes in triglycerides [ Time Frame: 0, 3, 6, 9, 12, 24 months ]
    Blood sampling

  6. Changes in bdnf-a [ Time Frame: 0, 12 months ]
    Blood sampling

  7. Change in physical fitness [ Time Frame: 0, 12, 24 months ]
    Progressive treadmill protocol

  8. Change in body composition (DXA scan) [ Time Frame: 0, 3, 6, 9, 12, 24 months ]
    DXA scan

  9. Change in sleep quality [ Time Frame: 0, 12, months ]
    Self-report using the PSQI questionnaire

  10. Change in sleepiness [ Time Frame: 0, 12, months ]
    Self-report using the Epsworth questionnaire

  11. Change in sleep pattern [ Time Frame: 0, 12, months ]
    Cardio-respiratory monitoring

  12. Change in the degree of depression [ Time Frame: 0, 12, 24 months ]
    Self-report using the BDI-II questionnaire

  13. Change in Glucose tolerance (2-h oral glucose tolerance test) [ Time Frame: 0, 12, 24 months ]
    2-h oral glucose tolerance test

  14. Change in Well-being [ Time Frame: 0, 12, 24 months ]
    Self-report using the questionnaire SF-36 and MFI20

  15. Change in motivation for exercise [ Time Frame: 0, 12, 24 months ]
    Self-report using the questionnaire BREQ-2

  16. Change in cognitive function [ Time Frame: 0, 12 months ]
    Self-report using the CANTAB test battery

  17. 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)

  18. 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

  19. 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

  20. Change in low grade inflammation [ Time Frame: 0, 12, 24 months ]
    The change in pro- and anti inflammatory markers will be evaluated



Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02417012


Locations
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Denmark
Center for Physical Activity Research, Copenhagen University Hospital
Copenhagen, Denmark, 2100
Sponsors and Collaborators
Rigshospitalet, Denmark
TRYG Foundation
Investigators
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Principal Investigator: Mathias Ried-Larsen, PhD Rigshospitalet, Denmark

Publications:
Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
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Responsible Party: Mathias Ried-Larsen, Group leader, Rigshospitalet, Denmark
ClinicalTrials.gov Identifier: NCT02417012     History of Changes
Other Study ID Numbers: U-TURN
First Posted: April 15, 2015    Key Record Dates
Last Update Posted: December 13, 2018
Last Verified: December 2018
Keywords provided by Mathias Ried-Larsen, Rigshospitalet, Denmark:
lifestyle
exercise
physical activity
diet
glycemic control
hba1c
glucose lowering drugs
Additional relevant MeSH terms:
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Diabetes Mellitus, Type 2
Diabetes Mellitus
Glucose Metabolism Disorders
Metabolic Diseases
Endocrine System Diseases