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Diabetes Mellitus Type 2NCT06687811

Carbohydrate Loading in Type 2 Diabetes Mellitus

A study testing preoperative carbohydrate loading in people with Diabetes Mellitus Type 2, run by Universitas Indonesia at 1 site in Indonesia.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial summary

The goal of this clinical trial is to learn the effects of preoperative carbohydrate loading on perioperative blood glucose levels and insulin resistance in type 2 diabetes mellitus undergo elective surgery. Read more about this study

Who is it for?
Ages 18 years and older
Conditions the study is for
Diabetes Mellitus Type 2
What is being tested?
preoperative carbohydrate loading
Could I receive a placebo?
Yes, some participants may receive a placebo
How many people
44 participants
Where
1 siteIndonesia
Study dates
22 Jun 2023to 31 Jan 2024
Phase
Interventional
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 years and older
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • Controlled type 2 diabetes mellitus with any treatment
  • BMI <30 kg/m2
  • Non-major elective surgery

Who cannot join

  • Subject refusal
  • Geriatric patients with frailty score >4
  • Subjects with critical illness
  • Subjects received steroid treatment
  • Subjects received total parenteral nutrition
  • Subjects with intestinal obstruction
  • Subjects with impaired liver function

Trial locations and contacts

1 site in 1 country.

Indonesia1 site

  • RSUPN Cipto Mangunkusumo

    Central Jakarta, Jakarta Special Capital Region, 10430

Other trials in Indonesia

About this study

Official title: The Effects of Preoperative Carbohydrate Loading on Perioperative Blood Glucose Levels and Insulin Resistance in Type 2 Diabetes Mellitus Patients Undergoing Elective Surgery

The goal of this clinical trial is to learn the effects of preoperative carbohydrate loading on perioperative blood glucose levels and insulin resistance in type 2 diabetes mellitus undergo elective surgery. The main questions it aims to answer are:

  • Does carbohydrate loading affects perioperative blood glucose and insulin resistance in type 2 diabetes mellitus patients undergo surgery?
  • How are the incident of perioperative hyperglycemia and hypoglycemia between subjects who receive placebo compared with subjects who receive carbohydrate loading
  • How are the hyperglycemia-related complications comparison between two groups?
Read more

Researchers will compare the carbohydrate loading intervention to placebo (regular drinking water with zero-calorie sweetener) to see the effects of carbohydrate loading to blood glucose levels and insulin resistance (by HOMA-IR value)

Participants will:

  • randomized to carbohydrate loading (CHO) group or placebo
  • checked for preoperative, intraoperative, postoperative blood glucose, and preoperative and postoperative insulin level
  • evaluated for any hyperglycaemia-related complications
Being tested
preoperative carbohydrate loading, Placebo
Keywords
Carbohydrate loading, Type 2 Diabetes Mellitus, Perioperative blood glucose, Insulin resistance
Medical subject headings
Diabetes Mellitus, Type 2, Insulin Resistance

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • preoperative carbohydrate loadingOther

    Also called CHO

    Patients receive 200 ml drink containing Maltodextrin 12.5%, 2 hours prior to surgery

  • PlaceboOther

    Also called Control

    Patients receive 200 ml regular drinking water with zero-calorie sweetener, 2 hours prior to surgery

Study groups in NCT06687811
Study groupRoleWhat they receive
Carbohydrate loading (CHO) groupActive comparatorPatient received preoperative carbohydrate loading of 200 ml Maltodextrin 12.5%, given 2 hours before the operation
Receives: Other: preoperative carbohydrate loading
ControlPlacebo comparatorPatient received preoperative regular drinking water of 200 ml with zero-calorie sweetener, given 2 hours before the operation
Receives: Other: Placebo

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Perioperative Blood Glucose Level

    Blood glucose sampled from vein and capillary, measured in mg/dL

    Measured: Preoperative (before intervention), 1 hour intraoperative, 30 minutes postoperative, 1 day postoperative

  2. Insulin Resistance

    Calculated using Homeostasis Model Assessment Insulin Resistance (HOMA-IR), obtained from measured fasting insulin (μU/ml) × fasting glucose (mmol/l) / 22.5

    Measured: preoperative and 30 minutes postoperative

Secondary outcomes (2)

  1. Abnormal blood glucose incidence

    Blood glucose level below 60 mg/dL (hypoglycaemia) or above 200 mg/dL (hyperglycaemia)

    Measured: Preoperative, 1 hour intraoperative, 30 minutes postoperative, 1 day postoperative

  2. Complications

    Hyperglycaemia-related complications, such as surgical site infection, aspiration, prolonged length of hospital stay

    Measured: Up to 1 week postoperative or discharged from hospital stay

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted14 Nov 2024
  2. Study start22 Jun 2023
  3. Primary completion20 Dec 2023
  4. Study completion31 Jan 2024

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase N/A
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Parallel groups
Masking
Quadruple blind
Who is masked
Participant, Care provider, Investigator, Outcomes assessor
Enrolment
44 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT06687811
Sponsor's protocol ID
IndonesiaUAnes093
Status last verified
Nov 2024
First submitted
10 Nov 2024
Last updated
14 Nov 2024
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
Yes: Individual participant data that underlie the results reported in this article, after deidentification

Publications

  • Ljungqvist O, Nygren J, Thorell A. Modulation of post-operative insulin resistance by pre-operative carbohydrate loading. Proc Nutr Soc. 2002 Aug;61(3):329-36. doi: 10.1079/PNS2002168.

    PubMed 12230794

  • Weledji EP, Njong SN, Chichom A, Verla V, Assob JC, Ngowe MN. The effects of preoperative carbohydrate loading on the metabolic response to surgery in a low resource setting. Int J Surg Open. 2017;8:18-23.

  • Robinson KN, Cassady BA, Hegazi RA, Wischmeyer PE. Preoperative carbohydrate loading in surgical patients with type 2 diabetes: Are concerns supported by data? Clin Nutr ESPEN. 2021 Oct;45:1-8. doi: 10.1016/j.clnesp.2021.08.023. Epub 2021 Sep 3.

    PubMed 34620304

  • Pogatschnik C, Steiger E. Review of Preoperative Carbohydrate Loading. Nutr Clin Pract. 2015 Oct;30(5):660-4. doi: 10.1177/0884533615594013. Epub 2015 Jul 21.

    PubMed 26197803

  • Bilku DK, Dennison AR, Hall TC, Metcalfe MS, Garcea G. Role of preoperative carbohydrate loading: a systematic review. Ann R Coll Surg Engl. 2014 Jan;96(1):15-22. doi: 10.1308/003588414X13824511650614.

    PubMed 24417824

  • Lin MW, Chen CI, Cheng TT, Huang CC, Tsai JW, Feng GM, Hwang TZ, Lam CF. Prolonged preoperative fasting induces postoperative insulin resistance by ER-stress mediated Glut4 down-regulation in skeletal muscles. Int J Med Sci. 2021 Jan 11;18(5):1189-1197. doi: 10.7150/ijms.52701. eCollection 2021.

    PubMed 33526980

  • Elias KM, Stone AB, McGinigle K, Tankou JI, Scott MJ, Fawcett WJ, Demartines N, Lobo DN, Ljungqvist O, Urman RD; ERAS(R) Society and ERAS(R) USA. The Reporting on ERAS Compliance, Outcomes, and Elements Research (RECOvER) Checklist: A Joint Statement by the ERAS(R) and ERAS(R) USA Societies. World J Surg. 2019 Jan;43(1):1-8. doi: 10.1007/s00268-018-4753-0.

    PubMed 30116862

  • Soop M, Nygren J, Myrenfors P, Thorell A, Ljungqvist O. Preoperative oral carbohydrate treatment attenuates immediate postoperative insulin resistance. Am J Physiol Endocrinol Metab. 2001 Apr;280(4):E576-83. doi: 10.1152/ajpendo.2001.280.4.E576.

    PubMed 11254464

  • Thorell A, Nygren J, Hirshman MF, Hayashi T, Nair KS, Horton ES, Goodyear LJ, Ljungqvist O. Surgery-induced insulin resistance in human patients: relation to glucose transport and utilization. Am J Physiol. 1999 Apr;276(4):E754-61. doi: 10.1152/ajpendo.1999.276.4.E754.

    PubMed 10198313

  • Gutch M, Kumar S, Razi SM, Gupta KK, Gupta A. Assessment of insulin sensitivity/resistance. Indian J Endocrinol Metab. 2015 Jan-Feb;19(1):160-4. doi: 10.4103/2230-8210.146874.

    PubMed 25593845

  • Duggan EW, Carlson K, Umpierrez GE. Perioperative Hyperglycemia Management: An Update. Anesthesiology. 2017 Mar;126(3):547-560. doi: 10.1097/ALN.0000000000001515.

    PubMed 28121636

  • Gillis C, Carli F. Promoting Perioperative Metabolic and Nutritional Care. Anesthesiology. 2015 Dec;123(6):1455-72. doi: 10.1097/ALN.0000000000000795.

    PubMed 26248016

  • Makuuchi R, Sugisawa N, Kaji S, Hikage M, Tokunaga M, Tanizawa Y, Bando E, Kawamura T, Terashima M. Enhanced recovery after surgery for gastric cancer and an assessment of preoperative carbohydrate loading. Eur J Surg Oncol. 2017 Jan;43(1):210-217. doi: 10.1016/j.ejso.2016.07.140. Epub 2016 Aug 10.

    PubMed 27554250

  • Albalawi Z, Laffin M, Gramlich L, Senior P, McAlister FA. Enhanced Recovery After Surgery (ERAS(R)) in Individuals with Diabetes: A Systematic Review. World J Surg. 2017 Aug;41(8):1927-1934. doi: 10.1007/s00268-017-3982-y.

    PubMed 28321553

  • Gustafsson UO, Nygren J, Thorell A, Soop M, Hellstrom PM, Ljungqvist O, Hagstrom-Toft E. Pre-operative carbohydrate loading may be used in type 2 diabetes patients. Acta Anaesthesiol Scand. 2008 Aug;52(7):946-51. doi: 10.1111/j.1399-6576.2008.01599.x. Epub 2008 Mar 7.

    PubMed 18331374

Questions about this trial

What is this clinical trial studying?

A study testing preoperative carbohydrate loading in people with Diabetes Mellitus Type 2, run by Universitas Indonesia at 1 site in Indonesia.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 3 inclusion and 7 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 14 Nov 2024. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in Indonesia. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Perioperative Blood Glucose Level (time frame: Preoperative (before intervention), 1 hour intraoperative, 30 minutes postoperative, 1 day postoperative). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT06687811, which also lists 19 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 14 Nov 2024.

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