Lifestyle and Glucose Lowering Medication in T2DM

Rigshospitalet, Denmark97 enrolled

Overview

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.

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

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

SINGLE

Enrollment

Conditions

Diabetes Mellitus, Type 2

Interventions

U-TURNBEHAVIORAL

Participants in this group will receive individual and group based interventions on obtaining and maintaining a healthy lifestyle, while having the pharmacological treatment regulated

Standard careBEHAVIORAL

Standard individual diabetes support

Eligibility

Sex: ALLMin age: 18 Years

Medical Language ↔ Plain English

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

Locations (1)

Center for Physical Activity Research, Copenhagen University Hospital

Copenhagen, Denmark

Outcomes

Primary Outcomes

Change in Hba1c

blood sampling of Hba1c

Time frame: 0, 3, 6, 9, 12 months

Secondary Outcomes

Change in glucose lowering medication

Change in doses of Metformin, GLP-1 analog, insulin. The change will be evaluate according to changes on the pre-specified regulation algorithm.

Time frame: 0, 3, 6, 9, 12 months

Data from ClinicalTrials.gov

This platform is for informational purposes only and does not constitute medical advice. Always consult a qualified healthcare professional.