Diabetes Mellitus, Type 2
Conditions
Keywords
lifestyle, exercise, physical activity, diet, glycemic control, hba1c, glucose lowering drugs
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.
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.
Interventions
BEHAVIORALU-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
BEHAVIORALStandard care
Standard individual diabetes support
Sponsors
TRYG Foundation
Rigshospitalet, Denmark
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
SINGLE (Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Change in Hba1c | 0, 3, 6, 9, 12 months | blood sampling of Hba1c |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Change in glucose lowering medication | 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
| Measure | Time frame | Description |
|---|---|---|
| incidence of hypo-glycemic episodes | 0, 3, 6, 9, 12, 24 months | Self-report to study nurse |
| Changes Ldl cholesterol | 0, 3, 6, 9, 12, 24 months | Blod sampling |
| Changes Hdl cholesterol | 0, 3, 6, 9, 12, 24 months | Blood sampling |
| Changes total cholesterol | 0, 3, 6, 9, 12, 24 months | Blood sampling |
| Changes in triglycerides | 0, 3, 6, 9, 12, 24 months | Blood sampling |
| Changes in bdnf-a | 0, 12 months | Blood sampling |
| Change in physical fitness | 0, 12, 24 months | Progressive treadmill protocol |
| Change in body composition (DXA scan) | 0, 3, 6, 9, 12, 24 months | DXA scan |
| Change in sleep pattern | 0, 12, months | Cardio-respiratory monitoring |
| Change in sleep quality | 0, 12, months | Self-report using the PSQI questionnaire |
| Change in Glucose tolerance (2-h oral glucose tolerance test) | 0, 12, 24 months | 2-h oral glucose tolerance test |
| Change in Well-being | 0, 12, 24 months | Self-report using the questionnaire SF-36 and MFI20 |
| Change in motivation for exercise | 0, 12, 24 months | Self-report using the questionnaire BREQ-2 |
| Change in cognitive function | 0, 12 months | Self-report using the CANTAB test battery |
| Change in arterial function | 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) |
| Partial T2D remission | 24 months | No active glucose lowering medication and HbA1c\<48 mmol/mol and Fasting blood glucose\<6,9 mmol/l |
| Full T2D remission | 24 months | No active glucose lowering medication and HbA1c\<39 mmol/mol and Fasting blood glucose\<5.6 mmol/l |
| Change in low grade inflammation | 0, 12, 24 months | The change in pro- and anti inflammatory markers will be evaluated |
| Change in the degree of depression | 0, 12, 24 months | Self-report using the BDI-II questionnaire |
| Change in sleepiness | 0, 12, months | Self-report using the Epsworth questionnaire |
Countries
Denmark
Outcome results
None listed