Prevalence of Major Nutrients Deficiency in Diabetic Patient Before and After Bariatric Surgery

Diabetic Patient Before and After Bariatric Surgery Clinical Trial

Official title:

Prevalence of Major Nutrients Deficiency in Diabetic Patient Before and After Bariatric Surgery

Clinical Trial Details — Status: Active, not recruiting

Administrative data

• NCT number: NCT03244839
• Other study ID #: 2016007
• Status: Active, not recruiting
• Phase: N/A
• First received: July 28, 2017
• Last updated: August 8, 2017
• Start date: January 2016
• Est. completion date: December 2018

Study information

• Verified date: July 2017
• Source: Min-Sheng General Hospital
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial Summary

The increasing demand of bariatric surgery requires ongoing improvement of the preoperative and post-operative care of morbidly obese patients. Outcome reporting in bariatric surgery mainly focuses on weight loss, improvement of co-morbidities and quality of life. Post-operative nutritional deficiencies are a complication of bariatric surgery, in particular after malabsorptive procedures. Deficiencies of protein, iron and vitamins B12 and D are frequently reported and may occur despite supplementation. Morbid obesity itself is associated with nutritional deficiencies as well, which become worsening after bariatric surgery. The occurrence of nutritional deficiencies has been reported in the literature but not in Taiwan. The goal of the current study is to determine the prevalence and incidence of nutritional deficiencies in diabetic patients underwent bariatric surgery and receiving standard supplementation in Taiwan.

Description:

The increasing demand of bariatric surgery requires ongoing improvement of the preoperative and post-operative care of morbidly obese patients. Outcome reporting in bariatric surgery mainly focuses on weight loss, improvement of co-morbidities and quality of life. Post-operative nutritional deficiencies are a complication of bariatric surgery, in particular after malabsorptive procedures. Deficiencies of protein, iron and vitamins B12 and D are frequently reported and may occur despite supplementation. Morbid obesity itself is associated with nutritional deficiencies as well, which become worsening after bariatric surgery. The occurrence of nutritional deficiencies has been reported in the literature but not in Taiwan. The goal of the current study is to determine the prevalence and incidence of nutritional deficiencies in diabetic patients underwent bariatric surgery and receiving standard supplementation in Taiwan

Recruitment information / eligibility

• Status: Active, not recruiting
• Enrollment: 200
• Est. completion date: December 2018
• Est. primary completion date: December 2018
• Accepts healthy volunteers: No
• Gender: All
• Age group: 20 Years to 65 Years

Eligibility

Inclusion Criteria:

• Age: 20~65

• Diabetic patients underwent bariatric surgery in MSGH

Exclusion Criteria:

• Pregnancy

• Cancer on treatment

• Uncontrolled psychiatric disease

• Drug or alcohol abuser

Related Conditions & MeSH terms

• Diabetic Patient Before and After Bariatric Surgery
• Nutrition Deficiency(VitB1 VitB12.Ca.Fe)

Intervention

Procedure:
• bariatric surgery
bariatric surgery

Locations

Country	Name	City	State
Taiwan	Min sheng general hospital	Taoyuan city

Sponsors (1)

Lead Sponsor	Collaborator
Min-Sheng General Hospital

Country where clinical trial is conducted

Taiwan, 

References & Publications (3)

Shiffman ML, Sugerman HJ, Kellum JM, Brewer WH, Moore EW. Gallstone formation after rapid weight loss: a prospective study in patients undergoing gastric bypass surgery for treatment of morbid obesity. Am J Gastroenterol. 1991 Aug;86(8):1000-5. — View Citation

Shiffman ML, Sugerman HJ, Kellum JM, Moore EW. Changes in gallbladder bile composition following gallstone formation and weight reduction. Gastroenterology. 1992 Jul;103(1):214-21. — View Citation

Williams C, Gowan R, Perey BJ. A Double-Blind Placebo-controlled Trial of Ursodeoxycholic Acid in the Prevention of Gallstones during Weight Loss after Vertical Banded Gastroplasty. Obes Surg. 1993 Aug;3(3):257-259. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Prevalence of major nutrients deficiency in diabetic patient before and after bariatric surgery	Prevalence of major nutrients deficiency in diabetic patient before and after bariatric surgery	3 years