Association Between Dietary Pattern and Glycemic Control... | NCT03388229

Studies
Association Between Dietary Pattern and Glycemic Control Among Type 2 Diabetes Patients in the Unites Arab Emirates

NCT03388229

Sponsor

Rashid Centre for Diabetes and Research

Status

Completed

Last Update Posted

Jan 3, 2018Actual

Enrollment

850Actual

Phase

Not provided

Conditions

Dietary Habits

Interventions

not an intervention

Countries

United Arab Emirates

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Jan 2018

Overall Recruitment Status or Expanded Access Status

Completed

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Aug 8, 2017Actual

Primary Completion Date

Dec 10, 2017Actual

Completion Date

Dec 20, 2017Actual

First Submitted Date

Dec 18, 2017

First Submission Date that Met QC Criteria

Dec 23, 2017

First Posted Date

Jan 2, 2018Actual

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Jan 2, 2018

Last Update Posted Date

Jan 3, 2018Actual

Sponsor/Collaborators Module

Responsible Party, by Official Title

Dr.Amena Sadiya, Team Leader-Lifestyle Clinic, Rashid Centre for Diabetes and ResearchPrincipal Investigator

Lead Sponsor

Rashid Centre for Diabetes and ResearchOTHER

Collaborators

Not provided

Oversight Module

Has Data Monitoring Committee (DMC)

Is FDA Regulated Drug

Is FDA Regulated Device

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

Brief Summary

Poor glycemic control in patients with Type 2 Diabetes (T2D) is due to multiple factors and suboptimal dietary pattern is one of them .Assessing eating/dietary patterns (combinations of different foods or food groups) among individuals with diabetes may be beneficial in understanding the focus areas of dietary modification among the Emirati community and further developing dietary interventions for management of T2D. Only a few observational studies are reported in this region exploring the eating practices, although none to the investigators knowledge described the frequency of consumption of food groups in the T2D patients in the United Arab Emirates(UAE). Hence, in this study the investigators aim to describe the trends in frequency of consumption of food groups and analyze the association of frequency of food item consumption and glycemic control among the T2D UAE patients.

This retrospective cross sectional study will include the data from Hospital information system of 800+ T2D patients to describe the trends in frequency of consumption of food groups and analyze the possible association of frequency of food group/item consumption and glycemic control.

Detailed Description

Type 2 diabetes (T2D) burden is not only increasing globally but also in the middle east region. Dietary intake plays a crucial role in ameliorating glycemia and other risk factors ,The aim of this study is to describe the trends in frequency of consumption of food groups and possible association with glycemic control among theT2D UAE patients.

This retrospective cross-sectional study was conducted among 800+ T2D diabetic aged ≥ 18 years, attending Rashid Centre for Diabetes and Research(RCDR) Centre located in UAE during January 2011 until January 2015. The dietary data will be collected from hospital records generated by dietitians after an interview based consultation using a structured pre-tested questionnaire. Multiple regression techniques will be used for model building, to determine the separate contribution of known confounders and food items with high carbohydrate and glycemic control.

Design Module

Study Type

Observational

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Target Follow-Up Duration

Not provided

Phases

Not provided

Interventional Study Design

Allocation

Not provided

Intervention Model

Biospecimen

No data available

No data is available for this block.

Enrollment

850Actual

Arms/Interventions Module

Arm Groups

Not provided

Interventions

Name	Type	Description	Arm Group Labels	Other Names
not an intervention	Behavioral	it was observation not intervention

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
association between frequency of food group/item consumption and HbA1c among T2D patients	to develop a regression model of association between frequency of food consumption and poor glycemic control (HbA1c<7%)	January 2011 until January 2015

Secondary Outcomes

Measure	Description	Time Frame
To measure the percentage of frequency of consumption of food groups among T2D patients ,	assess the food frequency consumption of food groups and food items	January 2011 until January 2015

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

Type 2 Diabetes
UAE nationals,
both males and females.
Age between ≥ 18years

Exclusion Criteria:

Patients underwent bariatric surgery
Pregnant women

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

18 Years

Maximum Age

Not provided

Standard Ages

AdultOlder Adult

Study Population

Patients attending Rashid Centre for Diabetes and Research care centre located in Ajman, UAE during January 2011 until January 2015.

Sampling Method

Non-Probability Sample

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

Not provided

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Rashid Centre for Diabetes and Research		Ajman			United Arab Emirates

References Module

Citations

PubMed Identifier	Type	Citation	Retractions
31406470	Derived	Sadiya A, Mnla R. Impact of food pattern on glycemic control among type 2 diabetic patients: a cross-sectional study in the United Arab Emirates. Diabetes Metab Syndr Obes. 2019 Jul 16;12:1143-1150. doi: 10.2147/DMSO.S209320. eCollection 2019.

ID	Term
D005247	Feeding Behavior
D003924	Diabetes Mellitus, Type 2

ID	Term
D001522	Behavior, Animal
D001519	Behavior
D003920	Diabetes Mellitus
D044882	Glucose Metabolism Disorders