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Lifestyle in Turkish-Background Diabetics

NCT ID: NCT03281616

Last Updated: 2017-09-19

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

110 participants

Study Classification

INTERVENTIONAL

Study Start Date

2014-06-01

Study Completion Date

2015-09-30

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.

Conditions

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Diabetes Mellitus

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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Diet and Physical Activity Recording

Group Type ACTIVE_COMPARATOR

Diet

Intervention Type BEHAVIORAL

Individually tailored diets; 30% caloric reduction according to daily energy requirements measured by indirect calorimetry

Diet and No Physical Activity Recording

Group Type ACTIVE_COMPARATOR

Diet

Intervention Type BEHAVIORAL

Individually tailored diets; 30% caloric reduction according to daily energy requirements measured by indirect calorimetry

Interventions

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Diet

Individually tailored diets; 30% caloric reduction according to daily energy requirements measured by indirect calorimetry

Intervention Type BEHAVIORAL

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
Minimum Eligible Age

30 Years

Maximum Eligible Age

65 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Charite University, Berlin, Germany

OTHER

Sponsor Role lead

Responsible Party

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Michael Boschmann

Physician

Responsibility Role PRINCIPAL_INVESTIGATOR

Other Identifiers

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Identifier Type: -

Identifier Source: org_study_id