NCT04105348

Brief Summary

Diabetes mellitus is a hyperglycemic metabolic disorder due to insulin deficiency or resistance at its receptors, leads to impaired glucose metabolism and multi-organ affection; (optic, peripheral neurological, cardiovascular and renal).

Trial Health

35
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 Oct 2019

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

September 24, 2019

Completed
2 days until next milestone

First Posted

Study publicly available on registry

September 26, 2019

Completed
5 days until next milestone

Study Start

First participant enrolled

October 1, 2019

Completed
1.7 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 1, 2021

Completed
4 months until next milestone

Study Completion

Last participant's last visit for all outcomes

October 1, 2021

Completed
Last Updated

October 1, 2019

Status Verified

September 1, 2019

Enrollment Period

1.7 years

First QC Date

September 24, 2019

Last Update Submit

September 29, 2019

Conditions

Outcome Measures

Primary Outcomes (1)

  • effect of IBD on DM

    patients with raised; HbA1c, fasting blood glucose, 2 hours postprandial blood glucose

    on addmision

Study Arms (2)

IBD with DM

Diagnostic Test: HbA1c

IBD without DM

Diagnostic Test: HbA1c

Interventions

HbA1cDIAGNOSTIC_TEST

patients with raised investigations will be included in group 1 patients with normal investigations will be included in group 2

Also known as: fasting blood glucose, 2 hours postprandial blood glucose
IBD with DMIBD without DM

Eligibility Criteria

Sexall
Healthy VolunteersNo
Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)
Sampling MethodProbability Sample
Study Population

IBD clinic or Patients addmited at El raghy hospital in assiut university with IBD

You may qualify if:

  • \- All patients with IBD admitted at EL-Raghy Assiut university hospital in the period of first of October 2019 to the end of September 2020 The diagnosis of DM is confirmed by high random blood glucose level more than 200mg/dl three times per day or high HbA1c more than 6.5%.
  • The diagnosis of IBD is confirmed by colonic biopsy results after colonoscopy.

You may not qualify if:

  • Patients didn't do colonoscopy or didn't get biopsy or with normal colonoscopy and biopsy

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Related Publications (5)

  • Cho NH, Shaw JE, Karuranga S, Huang Y, da Rocha Fernandes JD, Ohlrogge AW, Malanda B. IDF Diabetes Atlas: Global estimates of diabetes prevalence for 2017 and projections for 2045. Diabetes Res Clin Pract. 2018 Apr;138:271-281. doi: 10.1016/j.diabres.2018.02.023. Epub 2018 Feb 26.

    PMID: 29496507BACKGROUND
  • Basso PJ, Fonseca MT, Bonfa G, Alves VB, Sales-Campos H, Nardini V, Cardoso CR. Association among genetic predisposition, gut microbiota, and host immune response in the etiopathogenesis of inflammatory bowel disease. Braz J Med Biol Res. 2014 Sep;47(9):727-37. doi: 10.1590/1414-431x20143932. Epub 2014 Jul 25.

    PMID: 25075576BACKGROUND
  • Bernstein CN, Blanchard JF, Rawsthorne P, Yu N. The prevalence of extraintestinal diseases in inflammatory bowel disease: a population-based study. Am J Gastroenterol. 2001 Apr;96(4):1116-22. doi: 10.1111/j.1572-0241.2001.03756.x.

    PMID: 11316157BACKGROUND
  • Tigas S, Tsatsoulis A. Endocrine and metabolic manifestations in inflammatory bowel disease. Ann Gastroenterol. 2012;25(1):37-44.

    PMID: 24714153BACKGROUND
  • van Raalte DH, Ouwens DM, Diamant M. Novel insights into glucocorticoid-mediated diabetogenic effects: towards expansion of therapeutic options? Eur J Clin Invest. 2009 Feb;39(2):81-93. doi: 10.1111/j.1365-2362.2008.02067.x.

    PMID: 19200161BACKGROUND

MeSH Terms

Conditions

Inflammatory Bowel Diseases

Condition Hierarchy (Ancestors)

GastroenteritisGastrointestinal DiseasesDigestive System DiseasesIntestinal Diseases

Central Study Contacts

Fatema Abd El-Moez, professor

CONTACT

Lobna Ahmed, assisstant professor

CONTACT

Study Design

Study Type
observational
Observational Model
CASE ONLY
Time Perspective
CROSS SECTIONAL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
principal investigator

Study Record Dates

First Submitted

September 24, 2019

First Posted

September 26, 2019

Study Start

October 1, 2019

Primary Completion

June 1, 2021

Study Completion

October 1, 2021

Last Updated

October 1, 2019

Record last verified: 2019-09