- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT05791019
Efficacy of Paleolithic Diet in Control of Blood Level of Glucose in Type 2 DM Patients
March 29, 2023 updated by: Nagy Nageh Abdo, Assiut University
Efficacy of paleolithic diet in control of blood glucose level in type 2 DM patients
Study Overview
Status
Not yet recruiting
Conditions
Intervention / Treatment
Detailed Description
Diabetes mellitus has become one of the most common progressive chronic diseases in the world, with 422 million people affected worldwide.
Approximately 95% of people currently diagnosed with diabetes have type 2 diabetes mellitus (T2DM).
The disease is characterized by chronic hyperglycemia, which can impair pancreatic beta cell function and increase insulin resistance, deteriorating the metabolic condition and causing microvascular complications in the retina, kidney or peripheral nerves .
Thus, glycemic control is essential for diabetes management, in order to avoid complications in organs and systems, which are related with high morbidity and mortality rates.
Among T2DM causes are genetic and epigenetic elements interacting within a societal framework.
The genetic predisposition for T2DM takes into account the increased risk of an individual to develop T2DM when there are other family members affected.
On the other hand, epigenetic elements are those influenced by environmental factors, i. e., they can be reversible, and therefore manipulated, in order to treat the disease.
Regardless of the causes, the main targets of the treatment are focused on decreasing insulin resistance and improving beta cell function and decrease the inflammatory process through diet, exercise and antihyperglycemic agents.
Based on this, given the high prevalence of the disease and the significant benefits of its management, it is of clinical importance to determine the proper amount and type of carbohydrates in patients' diet, as they both may influence the glycemic index of a meal.
Besides, some foods' intake induce a marked rise followed by a more or less rapid fall in blood glucose, while others produce a smaller peak along with a more gradual decline in plasma glucose.
Currently, it is recommended for T2DM patients an intake of 26-44% of total daily energy from carbohydrates, preferably from high-quality sources, such as vegetables, whole fruits and legumes , which are rich in fiber.
Most fibers, which are unabsorbed carbohydrates, are insoluble and increase stool weight.
In contrast, starches are carbohydrates found in vegetables that are mostly broken down to sugars by digestive enzymes.
Resistant starch, also found in vegetables and whole fruits, escapes digestion, being fermented in the intestine as well as dietary fiber.
Although the quantity and the quality of carbohydrates in the diet influence blood glucose levels , influencing insulin secretion and gastric emptying, the most beneficial type, the ideal amount of dietary carbohydrates and the underlying mechanisms involved remain a matter of debate.
Thus, this study was designed to systematically review the effects of the type and amount of dietary carbohydrates in studies involving T2DM , in order to clarify these aspects for improving T2DM management.
Study Type
Observational
Enrollment (Anticipated)
100
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Contact
- Name: Nagy Nageh Abdo, Doctor
- Phone Number: 01069854486
- Email: nagynageh22@gmail.com
Study Contact Backup
- Name: Manal El-Sayed EzzEl-dine, Prof
- Phone Number: 01005826070
- Email: Manal_ezeldeen@yahoo.com
Study Locations
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-
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Assiut, Egypt
- Nagy Nageh Abdo
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Contact:
- Manal El-Sayed EzzEl-dine, Prof
- Phone Number: 01005826070
- Email: Manal_ezeldeen@yahoo.com
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Contact:
- Muhammed Abbas Said Muhammad El-Masry, Prof
- Phone Number: 01272196319
- Email: masaeedr@yahoo.com
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Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
20 years to 45 years (Adult)
Accepts Healthy Volunteers
N/A
Genders Eligible for Study
All
Sampling Method
Non-Probability Sample
Study Population
Newly diagnosed type 2 DM, age less than 45 years old, not less than 5 years of DM, not diagnosed to have type 1 DM, not having infection, not having history of bariatric surgery and not following deut regimen for weight reduction
Description
Inclusion Criteria:
- Newly diagnosed type 2 DM, age less than 45 years old
Exclusion Criteria:
- type 1 DM infection bariatric surgery not follow diet regimine before study at least 6 month not on medication for weight reduction
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Efficacy of paleolithic diet in control of blood glucose levels in type 2 DM patients
Time Frame: Baseline
|
Controlling of glucose levels in blood by using specific dietary system and notifying the number of participants who achieve good results
|
Baseline
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Investigators
- Study Director: Muhammed Abbas Said Muhammad El-Masry, Prof, Assiut university hospitals
Publications and helpful links
The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start (Anticipated)
June 1, 2023
Primary Completion (Anticipated)
July 1, 2024
Study Completion (Anticipated)
August 1, 2024
Study Registration Dates
First Submitted
March 17, 2023
First Submitted That Met QC Criteria
March 17, 2023
First Posted (Actual)
March 30, 2023
Study Record Updates
Last Update Posted (Actual)
March 31, 2023
Last Update Submitted That Met QC Criteria
March 29, 2023
Last Verified
March 1, 2023
More Information
Terms related to this study
Other Study ID Numbers
- Paleolithic diet and T2DM
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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