NCT02066831
Completed
Not Applicable
Diabetes Coaching Study
West German Center of Diabetes and Health1 site in 1 country202 target enrollmentFebruary 2014
ConditionsType 2 Diabetes Mellitus
Overview
- Phase
- Not Applicable
- Intervention
- Not specified
- Conditions
- Type 2 Diabetes Mellitus
- Sponsor
- West German Center of Diabetes and Health
- Enrollment
- 202
- Locations
- 1
- Primary Endpoint
- HbA1c
- Status
- Completed
- Last Updated
- 10 years ago
Overview
Brief Summary
The purpose of the study is to compare the effect of telemedical coaching versus telemedical control on HbA1c, weight, BMI, blood pressure, blood lipids, medication, nutrition, physical activity and quality of life in type 2 diabetes patients with poor glycaemic control.
Investigators
Eligibility Criteria
Inclusion Criteria
- •type 2 diabetes mellitus
- •hemoglobin A1c (HbA1c) \>7.5%
- •at leat two different antidiabetic drugs
- •body mass index \>27kg/m2
Exclusion Criteria
- •acute infections
- •diagnosed chronic diseases other than type 2 diabetes and hypertension, e.g. cancer, chronic obstructive pulmonary disease (COPD), asthma, dementia, chronic gut diseases, psychoses, liver cirrhosis, (macro-) nephropathy, kidney insufficiency with glomerular filtration rate (eGFR) \< 30ml / min / 1.73 m2
- •acute chemotherapy or chronic cortisol treatment
- •smoking cessation for less than 3 months and or planned smoking cessation during study
- •known intolerance of any ingredient of Almased (especially soy protein)
- •pregnancy or breast feeding, lack of contraception (women)
- •other study participation in the last 6 months prior to study start
Outcomes
Primary Outcomes
HbA1c
Time Frame: 12 months
Difference in HbA1c (at end of study vs. baseline) between the groups
Secondary Outcomes
- weight(12 months)
- antidiabetic medication(12 months)
- Cardiovascular risk parameters (blood pressure, blood lipids)(12 months)
- physical activity (step count)(12 months)
- nutrition(12 months)
- quality of life(12 months)
Study Sites (1)
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