NCT03281616

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.

Trial Health

100
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
110

participants targeted

Target at P50-P75 for not_applicable diabetes-mellitus

Timeline
Completed

Started Jun 2014

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

June 1, 2014

Completed
1.1 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 30, 2015

Completed
3 months until next milestone

Study Completion

Last participant's last visit for all outcomes

September 30, 2015

Completed
2 years until next milestone

First Submitted

Initial submission to the registry

September 11, 2017

Completed
2 days until next milestone

First Posted

Study publicly available on registry

September 13, 2017

Completed
Last Updated

September 19, 2017

Status Verified

September 1, 2017

Enrollment Period

1.1 years

First QC Date

September 11, 2017

Last Update Submit

September 18, 2017

Conditions

Diabetes Mellitus

Outcome Measures

Primary Outcomes (1)

  • Body weight reduction

    Changes in body weight (kg) within 12 weeks of diet

    12 weeks

Secondary Outcomes (2)

  • Blood glucose

    12 weeks

  • Blood HbA1c

    12 weeks

Study Arms (2)

Diet and Physical Activity Recording

ACTIVE COMPARATOR
Behavioral: Diet

Diet and No Physical Activity Recording

ACTIVE COMPARATOR
Behavioral: Diet

Interventions

DietBEHAVIORAL

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

Diet and No Physical Activity RecordingDiet and Physical Activity Recording

Eligibility Criteria

Age30 Years - 65 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

  • Pregnancy
  • more than 3 anti-diabetic drugs

Contact the study team to confirm eligibility.

Sponsors & Collaborators

MeSH Terms

Conditions

Diabetes Mellitus

Interventions

Diet

Condition Hierarchy (Ancestors)

Glucose Metabolism DisordersMetabolic DiseasesNutritional and Metabolic DiseasesEndocrine System Diseases

Intervention Hierarchy (Ancestors)

Nutritional Physiological PhenomenaDiet, Food, and NutritionPhysiological Phenomena

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Physician

Study Record Dates

First Submitted

September 11, 2017

First Posted

September 13, 2017

Study Start

June 1, 2014

Primary Completion

June 30, 2015

Study Completion

September 30, 2015

Last Updated

September 19, 2017

Record last verified: 2017-09

Data Sharing

IPD Sharing
Will not share