Evaluation of Micronutrients in Obese Patients
Condition: Nutritional Disorder
MeSH terms: Nutrition Disorders
Study type: Observational

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.
    

Detailed description: 
      CONSORT 2010 Flow Diagram

      Materials and methods:

      Recruitment Morbidly obese subjects attending clinic at Surgery department for laparoscopic
      sleeve gastrectomy Alexandria University Hospitals.

      Pre-assignment Details adult morbidly obese subjects were included age above 20 years, BMI
      above 40 Suffering from comorbidities as hypertension, DM, dyslipidemia. Assigned
      participants were clinically evaluated for comorbidities as hypertension, DM, dyslipidemia.

      As well as signs of nutritional deficiency as anemia, brittle nails.

      Group Information one group of participants eligible for laparoscopic sleeve gastrectomy were
      assigned according to their will to participate in study.

      Period of evaluation:

      First visit: preoperative for clinical assessment of participants, determine BMI and waist
      circumference and withdrawal of serum blood sample Second visit: within one month after
      surgery to make sure that no complication occurred after surgery.

      Third visit: nine months postoperative for revaluation of participants, determine BMI and
      waist circumference, and withdrawal of a serum blood sample

      Number of participants at initiating the period of study. They were 120 morbidly obese
      subjects. Number of participants at the end of the period of study. They were 107 subjects,
      13 obese subject withdraw from study as they didn't come during follow up period after 9
      months.

      Participants according Sex (69 females, and 38 male), with the mean age of 41.6±8.9 years.
      The mean preoperative BMI was 47.43±5.4 kg/m2. Then, they were evaluated 9 months after LSG.

      Preoperative and Postoperative Clinical characteristics and metabolic variables in studied
      subjects.

      Preoperative 9 months postoperative P Body weight (Kg) 129.7 ± 12.1 93.4 ±13.6 0.0013* BMI
      (kg/m2) 47.43±5.4 35.7±3.8 0.0052* Waist circumference (cm) 130.00 ± 4.68 91.82 ± 3.73 0.001*
      Systolic BP (mmHg) 146.0±17.0 132.0±11.0 0.001* Total cholesterol (mmol/L) 5.85 ± 0.41 4.64 ±
      0.31 0.035* Triglycerides (mmol/L) 2.20 ± 0.23 1.92 ± 0.24 0.106 HDL cholesterol (mmol/L)
      1.23 ± 0.19 1.39 ± 0.2 0.041* LDL cholesterol (mmol/L) 3.37 ± 0.23 2.97 ± 0.21 0.022* HOMA-IR
      2.64 ± 1.3 1.44 ± 0.81 0.013* S. Leptin (ng/ml) 102.87 ± 49.16 33.47 ±12.76 0.0001* CRP
      (mg/L) 8.4±5.91 3.2±2.98 0.001* Lipocalin 2 (µg/L) 107.24±36.8 51.6±12.73 0.001* Albumin
      (g/dl) 4.05±0.21 3.91±0.29 0.113

      *Statistically significant at (p≤0.05).

      Outcome measures:

      primarily was to investigate the value of zinc to copper ratio as possible biomarker of TE
      imbalance in morbidly obese subjects undergoing LSG.

      For detection of presence of micronutrient deficiency in morbid obesity in form of zinc to
      copper ratio and re-evaluate it after loss of weight

      Secondly to correlate it with lipocalin 2 (Lcn2) with respect to Anthropometric measurements
      and other metabolic markers prospectively.

      As zinc to copper ratio is considered as biomarker of micronutrient status; therefore,
      correlate it with other biomarkers of inflammation (lipocalin 2) and other parameters as BMI,
      FBG to determine if micronutrient status improve after weight loss or not Time frame: 9
      months.

      Follow-up and outcome parameters:

      All studied subjects will be followed up for early postoperative complications (within the
      first month) as Bleeding or Leak. Then they will be reviewed after 9 months postoperatively
      for assessment of anthropometric measurements, control of preoperative comorbidities, and
      manifestations of TE deficiencies (anemia, hair loss, teeth problems, edema. etc.).

      Anthropometric parameters

      Body mass index (BMI) and waist circumference will be measured preoperative and 9 months
      postoperative.

      Biochemical parameters

      Fasting blood samples will be collected from participants prior to surgery and nine months
      postoperative, after overnight fast and divided into two tubes; EDTA for complete blood
      count, the rest into plastic tubes and serum sample.

      Serum glucose and Total cholesterol, HDL- cholesterol, LDL- cholesterol, and triglyceride,
      total protein and Albumin. Serum iron (Fe), and ferritin.

      Serum insulin, Ceruloplasmin, Zn and Cu levels, CRP and lipocalin-2 (Lcn2) .

      Statistical analysis

      All data will be analyzed with Statistical Package for the Social Sciences version 20
      software (SPSS, Inc., Chicago, IL). Results will be displayed as mean ± SD. Paired Student's
      t-test used to compare the data pre-operative and nine months postoperative. The chi-squared
      test used for category variables. Spearman correlation coefficient used to detect the
      correlation between different variables. Statistical correlations calculated by Pearson's
      correlation test. P < 0.05 is considered significant.
    

Intervention name(s): laparoscopic sleeve gastrectomy
Intervention type(s): Procedure
Intervention description(s): bariatric surgery to loss weight
Observational model: Cohort
Time perspective: Prospective
Sampling method: Probability 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
      
Biospecimen description: 
      serum samples are stored at -80 for determination of serum copper and zinc and lipocalin 2
    
Keywords: obesity; zinc; copper; lipocalin 2