Clinical trial NCT03244839: Prevalence of Major Nutrients Deficiency in Diabetic Patient Before and After Bariatric Surgery
Official title: Prevalence of Major Nutrients Deficiency in Diabetic Patient Before and After Bariatric Surgery
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: Diabetic Patient Before and After Bariatric Surgery
Nutrition Deficiency(VitB1 VitB12.Ca.Fe)
Lead sponsor: Min-Sheng General Hospital
Sponsor class: OTHER
First posted: 2017-08-10
Enrollment: 200
Sex: ALL
Minimum age (years): 20
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: CASE_ONLY
Time perspective: PROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: Diabetic patients underwent bariatric surgery in MSGH

Brief 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.

Detailed 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

Eligibility criteria: 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

Primary outcomes:
measure: Prevalence of major nutrients deficiency in diabetic patient before and after bariatric surgery
timeFrame: 3 years
Secondary outcomes:
Other outcomes:
Locations:
city: Taoyuan city
country: Taiwan
facility: Min sheng general hospital
Study officials:
References:
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. doi: 10.1016/0016-5085(92)91115-k.
citation: 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.
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. doi: 10.1381/096089293765559278.