Clinical Trials Logo

Clinical Trial Details — Status: Not yet recruiting

Administrative data

NCT number NCT04105348
Other study ID # DM and IBD
Secondary ID
Status Not yet recruiting
Phase
First received
Last updated
Start date October 1, 2019
Est. completion date October 2021

Study information

Verified date September 2019
Source Assiut University
Contact Fatema Abd El-Moez, professor
Phone 00201006564000
Email fatemaelosily@yahoo.com
Is FDA regulated No
Health authority
Study type Observational

Clinical Trial 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).


Description:

Inflammatory bowel disease; (Crohn's disease and ulcerative colitis), is chronic relapsing inflammation in the gastrointestinal tract due to complex interactions among genetic, environmental, gut microbiome, and immunologic factors.

Inflammatory bowel disease treatment inhibits the abnormal inflammatory response to heal intestinal tissue, relieve the abdominal pain, the diarrhea and the fresh bleeding per rectum, also decreases the frequency of flare-ups and maintains remission.

Amino-salicylates and antibiotics are step I drugs act on the intestinal lining and on presented inflammatory masses.

Corticosteroids are step II drugs on failure of step I drugs for adequate control of the Inflammatory bowel disease and rapid relief of symptoms and inflammation.

The immune modifying agents as azathioprine and 6 mercaptopurine are step III drugs on failure of the steroids.

Biologic agents are anti Tumor necrotic factor agents (infliximab and adalimumab) and non anti Tumor necrotic factor agents (vedolizumab, ustekinumab and natalizumab).

Inflammatory bowel disease may have endocrinal and metabolic associations in the form of; lipid abnormalities and insulin resistance. Also, insulin resistance and hyperglycemia may be due to steroid use as steroid upgrades (hepatic gluconeogenesis, inhibition of glucose uptake in adipose tissue, and impairment of insulin action).

There is no epidemiological evidence that Inflammatory bowel disease is a definite risk factor for diabetes. In this study, the association of diabetes in patients with Inflammatory bowel disease will be determined.


Recruitment information / eligibility

Status Not yet recruiting
Enrollment 100
Est. completion date October 2021
Est. primary completion date June 2021
Accepts healthy volunteers No
Gender All
Age group N/A and older
Eligibility Inclusion Criteria:

- 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.

Exclusion Criteria:

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

Study Design


Intervention

Diagnostic Test:
HbA1c
patients with raised investigations will be included in group 1 patients with normal investigations will be included in group 2

Locations

Country Name City State
n/a

Sponsors (1)

Lead Sponsor Collaborator
Assiut University

References & Publications (5)

Basso PJ, Fonseca MT, Bonfá 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. Epub 2014 Jul 25. Review. — View Citation

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. — View Citation

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. — View Citation

Tigas S, Tsatsoulis A. Endocrine and metabolic manifestations in inflammatory bowel disease. Ann Gastroenterol. 2012;25(1):37-44. Review. — View Citation

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. Review. — View Citation

Outcome

Type Measure Description Time frame Safety issue
Primary effect of IBD on DM patients with raised; HbA1c, fasting blood glucose, 2 hours postprandial blood glucose on addmision
See also
  Status Clinical Trial Phase
Active, not recruiting NCT04046913 - The ADDapt Diet in Reducing Crohn's Disease Inflammation N/A
Active, not recruiting NCT04989907 - A Study in Adults With Ulcerative Colitis (UC) or Crohn's Disease (CD) Receiving Vedolizumab in Real-World Practice in Switzerland
Recruiting NCT05316584 - A Novel Remote Patient and Medication Monitoring Solution to Improve Adherence and PerSiStence With IBD Therapy N/A
Active, not recruiting NCT04990258 - A 24-month Real Life PErsistence Efficacy and Safety Study in IBD Patients in REMission Switched From Intravenous Infliximab to Subcutaneous Infliximab CT-P13 Remsima®SC
Completed NCT06216223 - Laser Versus Surgery in Anal Diseases in Inflammatory Bowel Patients N/A
Enrolling by invitation NCT06015789 - Self-care in Patients Affected by Inflammatory Bowel Disease and Caregivers' Contribution to Self-care
Recruiting NCT06065995 - StoMakker Mobile Application N/A
Recruiting NCT03282786 - Comparison of Carbon Dioxide (CO2) to Air Insufflation in Colonoscopy in Patients With Inflammatory Bowel Disease N/A
Recruiting NCT06002074 - SMART Program Impact on Quality of Life in Inflammatory Bowel Diseases N/A
Recruiting NCT04960826 - Study of an Environmental Risk Factor in Crohn's Disease
Recruiting NCT05413941 - Internet-based Cognitive Behavioral Therapy in Inflammatory Bowel Disease N/A
Completed NCT03668249 - A Study to Characterize Multidimensional Model to Predict the Course of Crohn's Disease (CD)
Completed NCT00721812 - A First Time In Human Study to Evaluate the Safety, Tolerability and Pharmacokinetics of GSK1399686 Phase 1
Recruiting NCT05809999 - IBD Neoplasia Surveillance RCT N/A
Recruiting NCT04138225 - The Ecological Role of Yeasts in the Human Gut
Recruiting NCT04991324 - Cholecalciferol Comedication in IBD - the 5C-study Phase 3
Completed NCT03173144 - Chronic Inflammatory Disease, Lifestyle and Treatment Response
Not yet recruiting NCT05043818 - A Clinical Study on the Screening of Intestinal Biomarkers in IBD Patients With Depression
Recruiting NCT03042091 - Neomycin and Metronidazole Hydrochloride With or Without Polyethylene Glycol in Reducing Infection in Patients Undergoing Elective Colorectal Surgery Early Phase 1
Completed NCT02874365 - Intestinal Stem Cells Characterization N/A