Diabetes MellitusNCT06722274
Nutritional Habits Among People With and Without Diabetes in Upper Egypt
An observational study of Diabetes Mellitus, run by Assiut University.
Trial summary
Type2 Diabetes is a serious chronic disease associated with numerous complications. It is pandemic disease due to worsening of diatery habits and westernization of diet. These complications contribute to nearly half (46.1%) of deaths occurring in adults under 60, the working-age population. Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Diabetes Mellitus
- How many people
- 178 participants
- Where
- No sites listed yet
- Study dates
- 1 Jan 2025to 1 Feb 2026
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
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
- Healthy volunteers accepted
- Adult, Older adult
Study population: diabetic cases from outpatient diabetic clinic, centre of diabetes and endocrine, Department of Internal medicine, Assiut university hospitals matched control
Who may be able to join
- adults participant whose age > 18or older .
- type 2 DM
Who cannot join
- Patients who have stroke patients who have dementia. CKD patients (as it affects appetite and diet)
Trial locations and contacts
No sites are listed yet. Contact the study team or a site near you to ask about taking part.
About this study
Type2 Diabetes is a serious chronic disease associated with numerous complications. It is pandemic disease due to worsening of diatery habits and westernization of diet. These complications contribute to nearly half (46.1%) of deaths occurring in adults under 60, the working-age population. With this alarming increase, and in order to decrease complications and diabetes-related mortality, this health problem requires a comprehensive management plan where patients should be educated to make informed decisions about diet, exercise, weight, and medications, as recommended by the American Diabetes Association (ADA).
the aim of the study is -to detect nutritional habits in our locality among diabetic patients comparing to non diabetics.
Read the detailed description
Recent analysis has reported that for the management of diabetes, only pharmacologic approaches are not sufficient. The management of diabetes is a multifactorial process involving life style and dietery factors that influence the treatment outcomes. There are also patient-related factors, such as self-care behaviors, that have a strong influence on glycemic intolerance.
Diabetes management necessitates both medication and lifestyle adjustments, which are associated with a decreased risk of death. people with T2DM find dietary advice confusing, contradictory, and report that understanding and making healthy eating choices are the most challenging parts of living with the condition. Therefore, national guidelines recommend that all patients with T2DM should receive individualized, ongoing dietary advice from a health professional with expertise in nutrition. The role standing of diet in controlling of diabetes is considered imperative; still, diabetes patients are unaware of how they should approach this issue to ensure good glycaemiccontrol .in Egypt no sufficient screening about diatery habits .hypothesis:there is difference in diatery habits between patients with and without diabetes
- Conditions
- Diabetes Mellitus
- Keywords
- Nutritional habits
- Medical subject headings
- Diabetes Mellitus
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| Group A | patients with diabetes | |
| Group B | healthy control (without diabetes) |
What is being measured
The primary outcome is the main question the study is designed to answer.
nutrition knowledge score
nutrition knowledge score: the questionnaire consisted of three domains: knowledge, self-efficacy, and practice, with a total of 30 questions distributed as follows: 10 questions assessing knowledge, 7 questions assessing self-efficacy, and 13 questions assessing practice
Measured: baseline
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted9 Dec 2024
- Study start1 Jan 2025 (estimated)
- Primary completion1 Jan 2026 (estimated)
- Study completion1 Feb 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (5)Papers the sponsor has linked to this study.
- Other trials for Diabetes MellitusStudies of the same condition, open and under way.
- More trials run by Assiut UniversityThe sponsor's other registered studies.
- 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
- Case-control
- Time perspective
- Retrospective
- Enrolment
- 178 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Assiut University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Mona Mohammed Ahmed Mohammed, Assiut University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06722274
- Sponsor's protocol ID
- Nutritional habits DM- Non DM
- Status last verified
- Dec 2024
- First submitted
- 5 Dec 2024
- Last updated
- 9 Dec 2024
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Publications
Bawazeer NM, Benajiba N, Alzaben AS. Translation, validity, and reliability of an Arabic version of the dietary questionnaire on nutrition knowledge, self-efficacy, and practice among Arab young adults. Asia Pac J Clin Nutr. 2023;32(2):196-205. doi: 10.6133/apjcn.202306_32(2).0002.
PubMed 37382317Sami W, Alabdulwahhab KM, Ab Hamid MR, Alasbali TA, Alwadani FA, Ahmad MS. Dietary Knowledge among Adults with Type 2 Diabetes-Kingdom of Saudi Arabia. Int J Environ Res Public Health. 2020 Jan 30;17(3):858. doi: 10.3390/ijerph17030858.
PubMed 32019083England CY, Thompson JL, Jago R, Cooper AR, Andrews RC. Development of a brief, reliable and valid diet assessment tool for impaired glucose tolerance and diabetes: the UK Diabetes and Diet Questionnaire. Public Health Nutr. 2017 Feb;20(2):191-199. doi: 10.1017/S1368980016002275. Epub 2016 Sep 9.
PubMed 27609314Patel YR, Gadiraju TV, Gaziano JM, Djousse L. Adherence to healthy lifestyle factors and risk of death in men with diabetes mellitus: The Physicians' Health Study. Clin Nutr. 2018 Feb;37(1):139-143. doi: 10.1016/j.clnu.2016.11.003. Epub 2016 Nov 11.
PubMed 27866759Saeedi P, Salpea P, Karuranga S, Petersohn I, Malanda B, Gregg EW, Unwin N, Wild SH, Williams R. Mortality attributable to diabetes in 20-79 years old adults, 2019 estimates: Results from the International Diabetes Federation Diabetes Atlas, 9th edition. Diabetes Res Clin Pract. 2020 Apr;162:108086. doi: 10.1016/j.diabres.2020.108086. Epub 2020 Feb 15.
PubMed 32068099
Study at a glance
From the registry record, last updated by the sponsor on 9 Dec 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Nutritional Habits Among People With and Without Diabetes in Upper Egypt
- ClinicalTrials.gov ID
- NCT06722274
- Acronym / sponsor ID
- Nutritional habits DM- Non DM
- Conditions
- Diabetes Mellitus
- Keywords
- Nutritional habits
- Study type
- Observational
- Recruitment status
- Not yet recruiting
- Enrolment
- 178 participants (estimated)
- Lead sponsor
- Assiut UniversityUniversity, hospital or other
- Study start
- 1 Jan 2025 (estimated)
- Primary completion
- 1 Jan 2026 (estimated)
- Study completion
- 1 Feb 2026 (estimated)
- First posted
- 9 Dec 2024 (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.
Type2 Diabetes is a serious chronic disease associated with numerous complications. It is pandemic disease due to worsening of diatery habits and westernization of diet. These complications contribute to nearly half (46.1%) of deaths occurring in adults under 60, the working-age population. With this alarming increase, and in order to decrease complications and diabetes-related mortality, this health problem requires a comprehensive management plan where patients should be educated to make informed decisions about diet, exercise, weight, and medications, as recommended by the American Diabetes Association (ADA).
the aim of the study is -to detect nutritional habits in our locality among diabetic patients comparing to non diabetics.
Detailed description
Recent analysis has reported that for the management of diabetes, only pharmacologic approaches are not sufficient. The management of diabetes is a multifactorial process involving life style and dietery factors that influence the treatment outcomes. There are also patient-related factors, such as self-care behaviors, that have a strong influence on glycemic intolerance.
Diabetes management necessitates both medication and lifestyle adjustments, which are associated with a decreased risk of death. people with T2DM find dietary advice confusing, contradictory, and report that understanding and making healthy eating choices are the most challenging parts of living with the condition. Therefore, national guidelines recommend that all patients with T2DM should receive individualized, ongoing dietary advice from a health professional with expertise in nutrition. The role standing of diet in controlling of diabetes is considered imperative; still, diabetes patients are unaware of how they should approach this issue to ensure good glycaemiccontrol .in Egypt no sufficient screening about diatery habits .hypothesis:there is difference in diatery habits between patients with and without diabetes
Study design
- Observational model
- Case-control
- Time perspective
- Retrospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Group A | – | –patients with diabetes |
| Group B | – | –healthy control (without diabetes) |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
- Study population
- diabetic cases from outpatient diabetic clinic, centre of diabetes and endocrine, Department of Internal medicine, Assiut university hospitals matched control
Key inclusion criteria (2 listed)
- adults participant whose age > 18or older .
- type 2 DM
Key exclusion criteria (1 listed)
- Patients who have stroke patients who have dementia. CKD patients (as it affects appetite and diet)
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
nutrition knowledge score
Time frame: baseline
nutrition knowledge score: the questionnaire consisted of three domains: knowledge, self-efficacy, and practice, with a total of 30 questions distributed as follows: 10 questions assessing knowledge, 7 questions assessing self-efficacy, and 13 questions assessing practice
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 9 Dec 2024.
- Results publication: PubMed 37382317Bawazeer NM, Benajiba N, Alzaben AS. Translation, validity, and reliability of an Arabic version of the dietary questionnaire on nutrition knowledge, self-efficacy, and practice among Arab young adults. Asia Pac J Clin Nutr. 2023;32(2):196-205. doi: 10.6133/apjcn.202306_32(2).0002.
- Results publication: PubMed 32019083Sami W, Alabdulwahhab KM, Ab Hamid MR, Alasbali TA, Alwadani FA, Ahmad MS. Dietary Knowledge among Adults with Type 2 Diabetes-Kingdom of Saudi Arabia. Int J Environ Res Public Health. 2020 Jan 30;17(3):858. doi: 10.3390/ijerph17030858.
- Results publication: PubMed 27609314England CY, Thompson JL, Jago R, Cooper AR, Andrews RC. Development of a brief, reliable and valid diet assessment tool for impaired glucose tolerance and diabetes: the UK Diabetes and Diet Questionnaire. Public Health Nutr. 2017 Feb;20(2):191-199. doi: 10.1017/S1368980016002275. Epub 2016 Sep 9.
- Results publication: PubMed 27866759Patel YR, Gadiraju TV, Gaziano JM, Djousse L. Adherence to healthy lifestyle factors and risk of death in men with diabetes mellitus: The Physicians' Health Study. Clin Nutr. 2018 Feb;37(1):139-143. doi: 10.1016/j.clnu.2016.11.003. Epub 2016 Nov 11.
- Results publication: PubMed 32068099Saeedi P, Salpea P, Karuranga S, Petersohn I, Malanda B, Gregg EW, Unwin N, Wild SH, Williams R. Mortality attributable to diabetes in 20-79 years old adults, 2019 estimates: Results from the International Diabetes Federation Diabetes Atlas, 9th edition. Diabetes Res Clin Pract. 2020 Apr;162:108086. doi: 10.1016/j.diabres.2020.108086. Epub 2020 Feb 15.
- Individual participant dataSharing planned: Undecided
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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.
Questions about this trial
What is this clinical trial studying?
An observational study of Diabetes Mellitus, run by Assiut University.
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 2 inclusion and 1 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: opening soon, as of the sponsor's last update on 9 Dec 2024. Status can change between updates, so confirm with the study contact before making plans.
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?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Mona Mohamed Ahmed Mohamed, resident doctor (+201110740797, monayossef1234567@gmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
nutrition knowledge score (time frame: baseline). 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 NCT06722274, which also lists 5 linked publications.
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 9 Dec 2024.