Lifestyle and Glucose Lowering Medication in T2DM

Diabetes Mellitus, Type 2 Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02417012
• Other study ID #: U-TURN
• Status: Completed
• Phase: N/A
• Start date: April 2015
• Est. completion date: September 2017

Study information

• Verified date: December 2018
• Source: Rigshospitalet, Denmark
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 97
• Est. completion date: September 2017
• Est. primary completion date: September 2017
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Diabetes Mellitus
• Diabetes Mellitus, Type 2

Intervention

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
• Standard care
Standard individual diabetes support

Locations

Country	Name	City	State
Denmark	Center for Physical Activity Research, Copenhagen University Hospital	Copenhagen

Sponsors (2)

Lead Sponsor	Collaborator
Rigshospitalet, Denmark	TRYG Foundation

Country where clinical trial is conducted

Denmark, 

References & Publications (1)

Pedersen BK, Saltin B. Evidence for prescribing exercise as therapy in chronic disease. Scand J Med Sci Sports. 2006 Feb;16 Suppl 1:3-63. Review. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	incidence of hypo-glycemic episodes	Self-report to study nurse	0, 3, 6, 9, 12, 24 months
Other	Changes Ldl cholesterol	Blod sampling	0, 3, 6, 9, 12, 24 months
Other	Changes Hdl cholesterol	Blood sampling	0, 3, 6, 9, 12, 24 months
Other	Changes total cholesterol	Blood sampling	0, 3, 6, 9, 12, 24 months
Other	Changes in triglycerides	Blood sampling	0, 3, 6, 9, 12, 24 months
Other	Changes in bdnf-a	Blood sampling	0, 12 months
Other	Change in physical fitness	Progressive treadmill protocol	0, 12, 24 months
Other	Change in body composition (DXA scan)	DXA scan	0, 3, 6, 9, 12, 24 months
Other	Change in sleep quality	Self-report using the PSQI questionnaire	0, 12, months
Other	Change in sleepiness	Self-report using the Epsworth questionnaire	0, 12, months
Other	Change in sleep pattern	Cardio-respiratory monitoring	0, 12, months
Other	Change in the degree of depression	Self-report using the BDI-II questionnaire	0, 12, 24 months
Other	Change in Glucose tolerance (2-h oral glucose tolerance test)	2-h oral glucose tolerance test	0, 12, 24 months
Other	Change in Well-being	Self-report using the questionnaire SF-36 and MFI20	0, 12, 24 months
Other	Change in motivation for exercise	Self-report using the questionnaire BREQ-2	0, 12, 24 months
Other	Change in cognitive function	Self-report using the CANTAB test battery	0, 12 months
Other	Change in arterial function	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
Other	Partial T2D remission	No active glucose lowering medication and HbA1c<48 mmol/mol and Fasting blood glucose<6,9 mmol/l	24 months
Other	Full T2D remission	No active glucose lowering medication and HbA1c<39 mmol/mol and Fasting blood glucose<5.6 mmol/l	24 months
Other	Change in low grade inflammation	The change in pro- and anti inflammatory markers will be evaluated	0, 12, 24 months
Primary	Change in Hba1c	blood sampling of Hba1c	0, 3, 6, 9, 12 months
Secondary	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.	0, 3, 6, 9, 12 months