Dietary HabitsNCT03388229
Association Between Dietary Pattern and Glycemic Control Among Type 2 Diabetes Patients in the Unites Arab Emirates
An observational study of Dietary Habits, run by Rashid Centre for Diabetes and Research at 1 site in United Arab Emirates.
Trial 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… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Dietary Habits
- What is being tested?
- not an intervention
- Type of treatment
- Lifestyle or therapy programme
- How many people
- 850 participants
- Where
- 1 siteUnited Arab Emirates
- Study dates
- 8 Aug 2017to 20 Dec 2017
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Patients attending Rashid Centre for Diabetes and Research care centre located in Ajman, UAE during January 2011 until January 2015.
Who may be able to join
- Type 2 Diabetes
- UAE nationals,
- both males and females.
- Age between ≥ 18years
Who cannot join
- Patients underwent bariatric surgery
- Pregnant women
Trial locations and contacts
1 site in 1 country.
United Arab Emirates1 site
Rashid Centre for Diabetes and Research
Ajman
About this study
Official title: Association Between Dietary Pattern and Glycemic Control Among Type 2 Diabetes Patients in the United Arab Emirates: A Retrospective Cross-sectional Study
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.
Read the 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.
- Conditions
- Dietary Habits
- Being tested
- not an intervention
- Keywords
- Dietary pattern, glycemic control, type 2 diabetes, UAE
- Medical subject headings
- Feeding Behavior, Diabetes Mellitus, Type 2
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
not an interventionBehavioural
it was observation not intervention
What is being measured
The primary outcome is the main question the study is designed to answer.
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%)
Measured: January 2011 until January 2015
Secondary outcomes (1)
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
Measured: January 2011 until January 2015
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted2 Jan 2018
- Study start8 Aug 2017
- Primary completion10 Dec 2017
- Study completion20 Dec 2017
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Dietary HabitsStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Other
- Time perspective
- Retrospective
- Enrolment
- 850 participants (actual)
Sponsor and investigators
- Lead sponsor
- Rashid Centre for Diabetes and Research
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Dr.Amena Sadiya, Rashid Centre for Diabetes and Research
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03388229
- Sponsor's protocol ID
- DietpatternUAE
- Status last verified
- Jan 2018
- First submitted
- 18 Dec 2017
- Last updated
- 3 Jan 2018
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
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.
PubMed 31406470
Study at a glance
From the registry record, last updated by the sponsor on 3 Jan 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Association Between Dietary Pattern and Glycemic Control Among Type 2 Diabetes Patients in the United Arab Emirates: A Retrospective Cross-sectional Study
- ClinicalTrials.gov ID
- NCT03388229
- Acronym / sponsor ID
- DietpatternUAE
- Conditions
- Dietary Habits
- Keywords
- Dietary pattern, glycemic control, type 2 diabetes, UAE
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 850 participants (actual)
- Lead sponsor
- Rashid Centre for Diabetes and ResearchUniversity, hospital or other
- Study start
- 8 Aug 2017 (actual)
- Primary completion
- 10 Dec 2017 (actual)
- Study completion
- 20 Dec 2017 (actual)
- First posted
- 2 Jan 2018 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Observational model
- Other
- Time perspective
- Retrospective
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Patients attending Rashid Centre for Diabetes and Research care centre located in Ajman, UAE during January 2011 until January 2015.
Key inclusion criteria (4 listed)
- Type 2 Diabetes
- UAE nationals,
- both males and females.
- Age between ≥ 18years
Key exclusion criteria (2 listed)
- Patients underwent bariatric surgery
- Pregnant women
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| not an interventionit was observation not intervention | Behavioural | – |
Primary outcome
association between frequency of food group/item consumption and HbA1c among T2D patients
Time frame: January 2011 until January 2015
to develop a regression model of association between frequency of food consumption and poor glycemic control (HbA1c<7%)
1 secondary outcome
To measure the percentage of frequency of consumption of food groups among T2D patients ,
Time frame: January 2011 until January 2015
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 3 Jan 2018.
- Derived from this study: PubMed 31406470Sadiya 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.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Dietary Habits, run by Rashid Centre for Diabetes and Research at 1 site in United Arab Emirates.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 3 Jan 2018. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United Arab Emirates. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
association between frequency of food group/item consumption and HbA1c among T2D patients (time frame: January 2011 until January 2015). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT03388229, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 3 Jan 2018.