Diabetes Mellitus
Conditions
Brief summary
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
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.
Interventions
BEHAVIORALDiet
Individually tailored diets; 30% caloric reduction according to daily energy requirements measured by indirect calorimetry
Sponsors
Charite University, Berlin, Germany
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
30 Years to 65 Years
Healthy volunteers
No
Inclusion criteria
* Age 30 - 65 years * BMI 30 - 40 kg/m2 * non-Insulin dependent diabetes
Exclusion criteria
* Pregnancy * more than 3 anti-diabetic drugs
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Body weight reduction | 12 weeks | Changes in body weight (kg) within 12 weeks of diet |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Blood glucose | 12 weeks | Changes in blood glucose (mmol/L) within 12 weeks of diet |
| Blood HbA1c | 12 weeks | Changes in blood glycated hemoglobin within 12 weeks of diet |
Outcome results
None listed