NCT03658564

Brief Summary

Insulin resistance is a positive protective reaction against surgery .this resistance has some negative consequences for patient health. It is associated with infectious complications. At the same time, Postoperative insulin resistance has been shown to correlate with the length of postoperative stay in hospital. Recently several clinical studies have shown that a carbohydrate-rich drink given 2 h before surgery diminishes postoperative insulin resistance in patient. The aim of our study is to investigate the influence on insulin resistance in patient with diabetes.

Trial Health

43
At Risk

Trial Health Score

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

Trial has exceeded expected completion date
Enrollment
80

participants targeted

Target at P50-P75 for not_applicable

Timeline
Completed

Started Sep 2018

Shorter than P25 for not_applicable

Geographic Reach
1 country

1 active site

Status
unknown

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

First Submitted

Initial submission to the registry

May 19, 2018

Completed
4 months until next milestone

First Posted

Study publicly available on registry

September 5, 2018

Completed
25 days until next milestone

Study Start

First participant enrolled

September 30, 2018

Completed
2 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 1, 2018

Completed
1 month until next milestone

Study Completion

Last participant's last visit for all outcomes

January 1, 2019

Completed
Last Updated

October 10, 2018

Status Verified

September 1, 2018

Enrollment Period

2 months

First QC Date

May 19, 2018

Last Update Submit

October 8, 2018

Conditions

Insulin Resistance

Keywords

Insulin resistanceDiabetes mellitusCarbohydrate

Outcome Measures

Primary Outcomes (1)

  • VAS

    Preoperative general well-beings before assessed with the visual analogue scale (VAS).

    1 day (preoperative period)

Secondary Outcomes (1)

  • HOMA

    perioperative period)

Study Arms (2)

Oral carbohydrate

EXPERIMENTAL

fast from midnight the night before surgery, and patients consume 400 ml Preoperative oral carbohydrate preOp®(12.5% carbohydrates, 0.5%kcal/ml, 240 mOsm, pH 4.9, Nutricia Zoetermeer, the Netherlands) 3 hours prior to induction of anesthesia and finished the ingestion within 20 minutes.

Dietary Supplement: Preoperative Oral Carbohydrate Drink

Fasting

NO INTERVENTION

fast from midnight the night before surgery, and no preoperative oral carbohydrate loading

Interventions

Preoperative Oral Carbohydrate DrinkDIETARY_SUPPLEMENT

Patients in Oral carbohydrate group consumed 400 ml Preoperative Oral Carbohydrate Drink Nutricia preOp® (12.5% carbohydrates, 0.5kcal/ml, 240 mOsm, pH 4.9, Nutricia Zoetermeer, the Netherlands) 3 hours prior to induction of anesthesia and finished the ingestion within 20 minutes.

Oral carbohydrate

Eligibility Criteria

Age20 Years - 65 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • patients underwent elective open colorectal resection for colorectal carcinoma and electric orthopedic surgery

You may not qualify if:

  • Weight loss greater than 10 per cent during the previous 6 months
  • Renal insufficiency (creatinine, \> 3 mg/dl; hemodialysis)
  • Hepatic insufficiency (Child-Pugh class, ≥ B)
  • Gastro-oesophageal reflux disease
  • Gastrointestinal obstruction or conditions (including pharmacological treatment) known to affect gastric emptying rate

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

The Second Hospital of Dalian Medical University

Dalian, Liaoning, 116000, China

RECRUITING

MeSH Terms

Conditions

Insulin ResistanceDiabetes Mellitus

Condition Hierarchy (Ancestors)

HyperinsulinismGlucose Metabolism DisordersMetabolic DiseasesNutritional and Metabolic DiseasesEndocrine System Diseases

Study Officials

  • yang z Xiao, MD,PhD

    0866-17709873399

    STUDY DIRECTOR

Central Study Contacts

yang z Xiao, MD,PhD

CONTACT

0866-17709873399xiaozhaoy@163.com

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
INVESTIGATOR
Purpose
PREVENTION
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

May 19, 2018

First Posted

September 5, 2018

Study Start

September 30, 2018

Primary Completion

December 1, 2018

Study Completion

January 1, 2019

Last Updated

October 10, 2018

Record last verified: 2018-09

Locations

CN(1)