Lifestyle in Turkish-Background Diabetics

Study Overview
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Brief Summary
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Background: Life-style interventions are indicated in patients with metabolic syndrome and/or type 2 diabetes. However, cultural differences are substantial confounders to not only compliance, but also whether or not the interventions are offered in the first place. In Germany, the large Turkish-background minority has a particularly high incidence of type 2 diabetes, but there is no recorded evidence of a life-style intervention in this patient group. Objective: The investigators tested the body weight-reducing effect of a 30% calorie-reduced diet, adjusted to individual eating habits and preferences regarding quality and resources of food in a Turkish-background cohort.

Detailed Description
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The investigators conducted a prospective, randomized, two-arm parallel study. In both arms, patients were instructed in a 12-week diet that was reduced by in caloric content by at least 30% based on calorimetric measurements of 24 h resting energy expenditure and estimated additional expenditures by diet- and activity-induced thermogenesis. Before and after the diet, anthropometric measures and various MetS-associated blood parameters were determined. The subjects were not instructed in an exercise program. However, the subjects were advised on the value of increased physical activity. For additional motivation, effects were tested by an activity monitor. Therefore, in one of the arms, 24 hour locomotor activity and energy expenditure were determined by means of the SenseWear® MF armband (Body Media Inc., AliphCom dba Jawbone®, Pittsburgh, PA, U.S.A.). This device detects activity contest using accelerometers and assesses daily energy expenditure. For allocation of the subjects, a computer-generated list of random numbers was used. The randomization sequence was created using SPSS 18 (SPSS, Inc., Chicago, IL, USA) statistical software and subjects were assigned to be tested or not for locomotor activity with a 1:1 allocation using random block sizes of 2, 4, and 6.

Official Title
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Lifestyle Interventions in Turkish-background Patients With Metabolic Syndrome and Diabetes in Germany

Conditions
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Diabetes Mellitus

Intervention / Treatment
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* Behavioral: Diet


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Age 30 - 65 years BMI 30 - 40 kg/m2 non-Insulin dependent diabetes Exclusion Criteria: Pregnancy more than 3 anti-diabetic drugs

Ages Eligible for Study
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Minimum Age: 30 Years
Maximum Age: 65 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: Diet and Physical Activity Recording<br> | Behavioral: Diet<br>* Individually tailored diets; 30% caloric reduction according to daily energy requirements measured by indirect calorimetry<br>|
| Active Comparator: Diet and No Physical Activity Recording<br> | Behavioral: Diet<br>* Individually tailored diets; 30% caloric reduction according to daily energy requirements measured by indirect calorimetry<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Body weight reduction | Changes in body weight (kg) within 12 weeks of diet | 12 weeks | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Blood glucose | Changes in blood glucose (mmol/L) within 12 weeks of diet | 12 weeks | 
| Blood HbA1c | Changes in blood glycated hemoglobin within 12 weeks of diet | 12 weeks |