NCT02469337

Brief Summary

The aim of the study is to investigate whether preoperative interventions such as carbohydrate drinks, Dichloroacetate and exercise would inhibit or reverse the changes in molecular mechanisms regulating muscle carbohydrate oxidation and postoperative muscle insulin resistance in patients undergoing major abdominal surgery.

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
40

participants targeted

Target at P25-P50 for phase_4

Timeline
Completed

Started May 2012

Longer than P75 for phase_4

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

Study Start

First participant enrolled

May 1, 2012

Completed
3.1 years until next milestone

First Submitted

Initial submission to the registry

June 8, 2015

Completed
3 days until next milestone

First Posted

Study publicly available on registry

June 11, 2015

Completed
2 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 1, 2017

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

June 1, 2017

Completed
Last Updated

January 5, 2017

Status Verified

January 1, 2017

Enrollment Period

5.1 years

First QC Date

June 8, 2015

Last Update Submit

January 4, 2017

Conditions

Insulin Resistance

Outcome Measures

Primary Outcomes (1)

  • insulin resistance

    Relative changes in indices of muscle insulin resistance namely PDC activity, PDK4 mRNA and protein expression.

    48 hours after surgery

Secondary Outcomes (2)

  • muscle carbohydrate oxidation

    48 hours after surgery

  • Mitochondrial ATP production

    48 hours after surgery

Study Arms (4)

Preoperative carbohydrate drinks

ACTIVE COMPARATOR

Patients who were randomised to carbohydrate group ingested 800ml PreOp (Nutricia Clinical Care, 12.5g CHO/100 ml) the night before and 400ml in the morning of surgery, about 2-3 hours before the induction of anaesthesia.

Dietary Supplement: Carbohydrate drinks

Dichloroacetate infusion

ACTIVE COMPARATOR

The patients in the dichloroacetate group received the CHO drinks as well as an intravenous infusion of DCA (50mg/kg body weight) over 45 min, one- two hours before the induction of anaesthesia.

Drug: Dichloroacetate

Moderate intensity exercise

ACTIVE COMPARATOR

Patients randomised to exercise group, will perform a 30 min exercise using a semi-recumbent exercise bike, at about 70% of their age estimated heart rate(determined by the formula: (220-Age)\*0.7 under close supervision and monitoring of their vital parameters.

Behavioral: Moderate intensity exercise

Control

NO INTERVENTION

Patients in this group will have surgery as standard practice with none of the above interventions

Interventions

DichloroacetateDRUG

Dichloroacetate, an analog of acetic acid has been shown to increase the activation of PDC by inhibiting PDK4 in humans. This drug is expected to shift the metabolism of pyruvate from glycolysis and towards oxidative pathway in the mitochondria

Also known as: sodium dichloroacetate
Dichloroacetate infusion
Carbohydrate drinksDIETARY_SUPPLEMENT

preoperative carbohydrate drinks

Preoperative carbohydrate drinks
Moderate intensity exerciseBEHAVIORAL

30 min exercise using a semi-recumbent exercise bike, at about 70% of their age estimated heart rate

Moderate intensity exercise

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • All patients over 18 years of age, who are undergoing major elective open abdominal surgery will be included in the study. Patients should be able to provide a written informed consent to participate in the study.

You may not qualify if:

  • Patients who are
  • Undergoing emergency surgery
  • Suffering from chronic illness, (e.g. diabetes) or other debilitating diseases
  • On long term anti-inflammatory drugs, (e.g. NSAIDS, Steroids, immunosuppressant)
  • On long term antibiotics
  • On Statins
  • On full therapeutic dose of anticoagulants, or aspirin \>325 mg/day, Clopidrogel \>75mg/day
  • Suffering from bleeding diathesis
  • Unable to give consent
  • Pregnant or breastfeeding.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

University Hospitals Nottingham Queen's Medical Centre

Nottingham, Nottingham, NG7 2UH, United Kingdom

Location

MeSH Terms

Conditions

Insulin Resistance

Interventions

Dichloroacetic Acid

Condition Hierarchy (Ancestors)

HyperinsulinismGlucose Metabolism DisordersMetabolic DiseasesNutritional and Metabolic Diseases

Intervention Hierarchy (Ancestors)

ChloroacetatesAcetatesAcids, AcyclicCarboxylic AcidsOrganic ChemicalsHydrocarbons, ChlorinatedHydrocarbons, HalogenatedHydrocarbons

Study Officials

  • Dileep N Lobo, Professor

    University of Nottingham

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
phase 4
Allocation
RANDOMIZED
Masking
NONE
Purpose
BASIC SCIENCE
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

June 8, 2015

First Posted

June 11, 2015

Study Start

May 1, 2012

Primary Completion

June 1, 2017

Study Completion

June 1, 2017

Last Updated

January 5, 2017

Record last verified: 2017-01

Data Sharing

IPD Sharing
Will not share

Locations

GB(1)