NCT05791019

Brief Summary

Efficacy of paleolithic diet in control of blood glucose level in type 2 DM patients

Trial Health

43
At Risk

Trial Health Score

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

Trial has exceeded expected completion date
Enrollment
100

participants targeted

Target at P50-P75 for all trials

Timeline
Completed

Started Jun 2023

Geographic Reach
1 country

1 active site

Status
unknown

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

First Submitted

Initial submission to the registry

March 17, 2023

Completed
13 days until next milestone

First Posted

Study publicly available on registry

March 30, 2023

Completed
2 months until next milestone

Study Start

First participant enrolled

June 1, 2023

Completed
1.1 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

July 1, 2024

Completed
1 month until next milestone

Study Completion

Last participant's last visit for all outcomes

August 1, 2024

Completed
Last Updated

March 31, 2023

Status Verified

March 1, 2023

Enrollment Period

1.1 years

First QC Date

March 17, 2023

Last Update Submit

March 29, 2023

Conditions

Diabetic Patients

Outcome Measures

Primary Outcomes (1)

  • Efficacy of paleolithic diet in control of blood glucose levels in type 2 DM patients

    Controlling of glucose levels in blood by using specific dietary system and notifying the number of participants who achieve good results

    Baseline

Interventions

Paleolithic diet effect on patientsOTHER

Efficacy of paleolithic diet in control of blood level of glucose in type 2 DM patients

Eligibility Criteria

Age20 Years - 45 Years
Sexall
Age GroupsAdult (18-64)
Sampling MethodNon-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

You may qualify if:

  • Newly diagnosed type 2 DM, age less than 45 years old

You may not qualify if:

  • type 1 DM infection bariatric surgery not follow diet regimine before study at least 6 month not on medication for weight reduction

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Nagy Nageh Abdo

Asyut, Egypt

Location

Related Publications (1)

  • Kleiner A, Cum B, Pisciotta L, Cincione IR, Cogorno L, Prigione A, Tramacere A, Vignati A, Carmisciano L, Sukkar SG. Safety and Efficacy of Eucaloric Very Low-Carb Diet (EVLCD) in Type 1 Diabetes: A One-Year Real-Life Retrospective Experience. Nutrients. 2022 Aug 5;14(15):3208. doi: 10.3390/nu14153208.

    PMID: 35956384BACKGROUND

Study Officials

  • Muhammed Abbas Said Muhammad El-Masry, Prof

    Assiut university hospitals

    STUDY DIRECTOR

Central Study Contacts

Nagy Nageh Abdo, Doctor

CONTACT

01069854486nagynageh22@gmail.com

Manal El-Sayed EzzEl-dine, Prof

CONTACT

01005826070Manal_ezeldeen@yahoo.com

Study Design

Study Type
observational
Observational Model
CASE CONTROL
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Assistant lecturer

Study Record Dates

First Submitted

March 17, 2023

First Posted

March 30, 2023

Study Start

June 1, 2023

Primary Completion

July 1, 2024

Study Completion

August 1, 2024

Last Updated

March 31, 2023

Record last verified: 2023-03

Locations

EG(1)