Diabetes Mellitus Clinical Trial
Official title:
Lifestyle Interventions in Turkish-background Patients With Metabolic Syndrome and Diabetes in Germany
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.
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.
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