NCT04554082

Brief Summary

The aim of the study primarily was to investigate the value of zinc to copper ratio as possible biomarker of trace elements imbalance in morbidly obese subjects undergoing LSG. Secondly to correlate zinc to copper ratio with lipocalin 2 (Lcn2) with respect to Anthropometric measurements and other metabolic biomarkers. Prospective study will be carried out on 120 morbidly obese adult subjects with a body mass index (BMI) score above 40 along with presence of obesity-related comorbidity. Investigations will be measured preoperative and 9 months postoperative after performing Laparoscopic sleeve gastrectomy; for Body mass index (BMI) and waist circumference. As well as for complete blood count and biochemical biomarkers as fasting blood glucose, lipid profile, serum iron and ferritin. Serum Ceruloplasmin, Zn and Cu levels, followed by calculation of zinc to copper ratio. CRP, serum insulin, serum leptin and lipocalin-2 (Lcn2) will be determined.

Trial Health

100
On Track

Trial Health Score

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

Enrollment
107

participants targeted

Target at P50-P75 for all trials

Timeline
Completed

Started Jan 2015

Longer than P75 for all trials

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

January 1, 2015

Completed
5 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

January 1, 2020

Completed
3 months until next milestone

Study Completion

Last participant's last visit for all outcomes

April 1, 2020

Completed
5 months until next milestone

First Submitted

Initial submission to the registry

September 6, 2020

Completed
12 days until next milestone

First Posted

Study publicly available on registry

September 18, 2020

Completed
Last Updated

September 18, 2020

Status Verified

September 1, 2020

Enrollment Period

5 years

First QC Date

September 6, 2020

Last Update Submit

September 13, 2020

Conditions

Nutritional Disorder

Keywords

obesityzinccopperlipocalin 2

Outcome Measures

Primary Outcomes (1)

  • Evaluation of zinc to copper ratio as biomarker of micro-nutrient deficiency

    detect if there are micronutrient deficiency in morbid obesity in form of zinc to copper ratio and re-evaluate it after loss of weight

    nine months

Secondary Outcomes (1)

  • correlate zinc to copper ratio to lipocalin 2 and other metabolic biomarkers

    nine months

Study Arms (2)

Preoperative Clinical characteristics and metabolic biomarkers

BMI and biochemical parameters including trace elements in patients undergoing laparoscopic sleeve gastrectomy before surgery

Procedure: laparoscopic sleeve gastrectomy

9 months' Postoperative metabolic biomarkers

BMI and biochemical parameters including trace elements in patients 9 months after laparoscopic sleeve gastrectomy

Procedure: laparoscopic sleeve gastrectomy

Interventions

laparoscopic sleeve gastrectomyPROCEDURE

bariatric surgery to loss weight

9 months' Postoperative metabolic biomarkersPreoperative Clinical characteristics and metabolic biomarkers

Eligibility Criteria

Age20 Years - 55 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64)
Sampling MethodProbability Sample
Study Population

adult obese subjects with BMI above 40 both males and females presence of obesity comorbidities as hypertension, insulin resistance "type 2 DM" eligible for laporoscopic sleeve gatrectomy

You may qualify if:

  • micronutrient deficiency in morbid obese subjects Adults.
  • BMI above 40
  • presence of comorbidities as hypertenion, DM, dislipidemia

You may not qualify if:

  • all causes which might cause micronutrient deficiency as presence of gastroesophageal reflux
  • all causes which may cause increase obesity "BMI" as hormonal disturbance ; hypothyroidism or cushing, females receiving contraceptive pills

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Related Publications (1)

  • Yerlikaya FH, Toker A, Aribas A. Serum trace elements in obese women with or without diabetes. Indian J Med Res. 2013 Feb;137(2):339-45.

    PMID: 23563378BACKGROUND

Biospecimen

Retention: SAMPLES WITHOUT DNA

serum samples are stored at -80 for determination of serum copper and zinc and lipocalin 2

MeSH Terms

Conditions

Nutrition DisordersObesity

Condition Hierarchy (Ancestors)

Nutritional and Metabolic DiseasesOverweightOvernutritionBody WeightSigns and SymptomsPathological Conditions, Signs and Symptoms

Study Officials

  • Hala M Demerdash, MD

    Alexandria University Hospitals

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Consultant Clinical Pathology

Study Record Dates

First Submitted

September 6, 2020

First Posted

September 18, 2020

Study Start

January 1, 2015

Primary Completion

January 1, 2020

Study Completion

April 1, 2020

Last Updated

September 18, 2020

Record last verified: 2020-09

Data Sharing

IPD Sharing
Will not share