Lifestyle in Turkish-Background Diabetics

Diabetes Mellitus Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03281616
• Other study ID #: Refine
• Status: Completed
• Phase: N/A
• First received: September 11, 2017
• Last updated: September 18, 2017
• Start date: June 1, 2014
• Est. completion date: September 30, 2015

Study information

• Verified date: September 2017
• Source: Charite University, Berlin, Germany
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 110
• Est. completion date: September 30, 2015
• Est. primary completion date: June 30, 2015
• Accepts healthy volunteers: No
• Gender: All
• Age group: 30 Years to 65 Years

Eligibility

Inclusion Criteria:

• Age 30 - 65 years

• BMI 30 - 40 kg/m2

• non-Insulin dependent diabetes

Exclusion Criteria:

• Pregnancy

• more than 3 anti-diabetic drugs

Related Conditions & MeSH terms

• Diabetes Mellitus

Intervention

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

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Charite University, Berlin, Germany

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Body weight reduction	Changes in body weight (kg) within 12 weeks of diet	12 weeks
Secondary	Blood glucose	Changes in blood glucose (mmol/L) within 12 weeks of diet	12 weeks
Secondary	Blood HbA1c	Changes in blood glycated hemoglobin within 12 weeks of diet	12 weeks