Long Term Effect of Splenectomy on Metabolism

NCT03648307 | Completed DMC

• 1 other identifier: ImamHGH
• Study Type: observational
• Target: 154
• Locations: 0 countries
• Sites: N/A

Brief Summary

Metabolic status of patients who had gone through trauma splenectomy between July 2008 and July 2013 were compared to patients who had gone through bowel resection due to obstruction in the same period of time. all patients were followed up for 5-10 years.

Conditions

Trauma Splenic

Keywords

Splenectomy; metabolism; diabetes; stem cells; trauma surgery

Outcome Measures

Primary Outcomes (1)

• Glucose tolerance

  Glucose tolerance was assessed by measuring the Hb A1C of the patients in both groups.

  July 2008- July 2013

Study Arms (2)

Trauma splenectomized

Patients who had gone through trauma splenectomy. BMI, lipid profile, blood pressure and glucose tolerance of patients were assessed. Hb A1C and lipid profile were assessed through blood sampling.

Diagnostic Test: Blood sample

Bowel resection

Patients who had gone through bowel resection due to obstruction. BMI, lipid profile, blood pressure and glucose tolerance of patients were assessed. Hb A1C and lipid profile were assessed through blood sampling.

Diagnostic Test: Blood sample

Interventions

Blood sample DIAGNOSTIC_TEST

Blood sample for Hb A1C and lipid profile, blood pressure and BMI

Also known as: BMI and blood pressure measurement

Bowel resection; Trauma splenectomized

Eligibility Criteria

• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Patients who had gone through bowel resection due to obstruction or trauma splenectomy in Imam Hosein General Hospital between July 2008 and July 2013

You may qualify if:

• trauma splenectomy or bowel resection due to obstruction between July 2008 and July 2013

You may not qualify if:

• disturbed lipid profile at the time of surgery
• disturbed blood glucose at the time of surgery
• history of high blood pressure at the time of surgery
• use of any hyperglcemogenic agent during the follow up
• BMI\>= 25 at the time of surgery
• history of diseases that can affect blood glucose levels
• accidental pancreatic damage during surgery
• resection of \> 10 cm of small bowel (for bowel resection group)
• history of malignancy or radiotherapy (for bowel resection group)

Sponsors & Collaborators

• Imam Hossein General Hospital: lead

Biospecimen

Retention: SAMPLES WITHOUT DNA

Blood samples for lipid profile and Hb A1C

MeSH Terms

Conditions

Diabetes Mellitus

Interventions

Blood Specimen Collection; Body Mass Index; Blood Pressure Determination

Condition Hierarchy (Ancestors)

Glucose Metabolism Disorders; Metabolic Diseases; Nutritional and Metabolic Diseases; Endocrine System Diseases

Intervention Hierarchy (Ancestors)

Specimen Handling; Clinical Laboratory Techniques; Diagnostic Techniques and Procedures; Diagnosis; Punctures; Surgical Procedures, Operative; Investigative Techniques; Body Weights and Measures; Body Constitution; Physical Examination; Anthropometry; Physiological Phenomena; Biometry; Epidemiologic Measurements; Public Health; Environment and Public Health; Diagnostic Techniques, Cardiovascular

Study Officials

• Behzad Nemati Honar, professor

  Imam Hosein General Hospital

  STUDY DIRECTOR

• Sahar Saeedi, MD

  Imam Hosein General Hospital

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: RETROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Researcher at Imam Hossein General Hospital, Medical Doctor

Study Record Dates

• First Submitted: August 18, 2018
• First Posted: August 27, 2018
• Study Start: July 1, 2008
• Primary Completion: July 1, 2018
• Study Completion: August 1, 2018
• Last Updated: August 27, 2018

Record last verified: 2018-08

Data Sharing

• IPD Sharing: Will not share