Diabetes Mellitus and Inflammatory Bowel Disease

NCT ID: NCT04105348

Last Updated: 2019-10-01

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Total Enrollment

100 participants

Study Classification

OBSERVATIONAL

Study Start Date

2019-10-01

Study Completion Date

2021-10-31

Brief Summary

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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).

Detailed Description

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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.

Conditions

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Inflammatory Bowel Diseases

Study Design

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Observational Model Type

CASE_ONLY

Study Time Perspective

CROSS_SECTIONAL

Study Groups

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IBD with DM

HbA1c

Intervention Type DIAGNOSTIC_TEST

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

IBD without DM

HbA1c

Intervention Type DIAGNOSTIC_TEST

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

Interventions

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HbA1c

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

Intervention Type DIAGNOSTIC_TEST

Other Intervention Names

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fasting blood glucose 2 hours postprandial blood glucose

Eligibility Criteria

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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
Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Assiut University

OTHER

Sponsor Role lead

Responsible Party

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MM Youssif

principal investigator

Responsibility Role PRINCIPAL_INVESTIGATOR

Central Contacts

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Fatema Abd El-Moez, professor

Role: CONTACT

00201006564000

Lobna Ahmed, assisstant professor

Role: CONTACT

00201093337630

References

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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.

Reference Type BACKGROUND
PMID: 29496507 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 25075576 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 11316157 (View on PubMed)

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

Reference Type BACKGROUND
PMID: 24714153 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 19200161 (View on PubMed)

Other Identifiers

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DM and IBD

Identifier Type: -

Identifier Source: org_study_id

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