Lifestyle in Turkish-Background Diabetics

Not Applicable

Completed

• Conditions: Diabetes Mellitus
• Interventions: Behavioral: Diet

• Registration Number: NCT03281616
• Lead Sponsor: Charite University, Berlin, Germany

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.

Study Timeline

• Study Start: 2014-06-01
• Primary Completion: 2015-06-30
• Study Completion: 2015-09-30
• Status Verified: 2017-09
• Study First Submitted: 2017-09-11
• Study First Submitted QC: 2017-09-11
• Study First Posted: 2017-09-13
• Last Update Submitted: 2017-09-18
• Last Update Posted: 2017-09-19

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 110

Inclusion Criteria

• Age 30 - 65 years
• BMI 30 - 40 kg/m2
• non-Insulin dependent diabetes

Exclusion Criteria

• Pregnancy
• more than 3 anti-diabetic drugs

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Diet and No Physical Activity Recording	Diet	-
Diet and Physical Activity Recording	Diet	-

Primary Outcome Measures

Name	Time	Method
Body weight reduction	12 weeks	Changes in body weight (kg) within 12 weeks of diet

Secondary Outcome Measures

Name	Time	Method
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