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DiabetesNCT04013594

Effect of Preoperative Oral Carbohydrates on the Glycemic Variability of Diabetic Patients

A study testing carbohydrate group in people with Diabetes, run by Yonsei University at 1 site in South Korea.

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

Preoperative carbohydrate drink intake attenuate insulin resistance. However, carbohydrate loading may compromise blood glucose control in patients with diabetes. There is some evidence that oral carbohydrate loading may be safe in patients with type 2 diabetes. Read more about this study

Who is it for?
Ages 19 years and older
Conditions the study is for
Diabetes
What is being tested?
carbohydrate group
Type of treatment
Pill or oral medicine
Could I receive a placebo?
No, everyone receives an active treatment
How many people
50 participants
Where
1 siteSouth Korea
Study dates
20 Aug 2019to 15 Oct 2020
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 19 years and older
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • 1. Patients undergoing total knee arthroplasty

Who cannot join

  • 1. Patients with contraindications to spinal anesthesia (local infection, clotting disorders, anatomical abnormalities, sepsis, etc.)
  • 2. Patients with gastroesophageal reflux disease, gastric emptying disorders, inflammatory bowel disease, or previous treatment for intra-abdominal cancer
  • 3. Patients with chronic renal disease or severe cardiovascular disease
  • 4. HbA1c >69 mmol/mol or BMI >30 kg/m2
  • 5. A duration of ≥5 hours between consumption of CHO and initiation of surgery.
  • 6. The subject is a foreigner or illiterate

Trial locations and contacts

1 site in 1 country.

South Korea1 site

  • Department of Anesthesiology and Pain Medicine, Anesthesia and Pain Research Institue, Yonsei Universiy College of Medicine

    Seoul, 03722

Other trials in South Korea

About this study

Preoperative carbohydrate drink intake attenuate insulin resistance. However, carbohydrate loading may compromise blood glucose control in patients with diabetes. There is some evidence that oral carbohydrate loading may be safe in patients with type 2 diabetes. Therefore, the investigators aim to evaluate whether preoperative carbohydrate intake affects insulin resistance and glycemic variability in patients with diabetes. Fifty patients scheduled for total knee arthroplasty will be divided into carbohydrate (n=25) and control (n=25) groups. Randomly selected patients of the carbohydrate group are given 400ml of 12.8 g/100 ml carbohydrate beverage 2-3 hours before their scheduled operation. In contrast, patients in the control group are fasted from water 2 hours before surgery according to standard protocol.

Conditions
Diabetes
Being tested
carbohydrate group
Medical subject headings
Diabetes Mellitus

What participants receive

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

  • carbohydrate groupDietary supplement

    Randomly selected patients of the carbohydrate group are given oral carbohydrate (400ml) 2-3 hours before surgery.

Study groups in NCT04013594
Study groupRoleWhat they receive
carbohydrate group(CHO group)ExperimentalNot described
Receives: Dietary Supplement: carbohydrate group
control groupNo interventionNot described

What is being measured

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

  1. Glycemic variability

    • Coefficient of glucose variability =SD/mean x 100 (%)

    Measured: Before anesthesia

  2. Glycemic variability

    • J index=0.001 x (MBG +SD)2 mg/dL

    Measured: Before anesthesia

  3. Glycemic variability

    • Coefficient of glucose variability =SD/mean x 100 (%)

    Measured: immediately after anesthesia

  4. Glycemic variability

    • J index=0.001 x (MBG +SD)2 mg/dL

    Measured: immediately after anesthesia

  5. Glycemic variability

    • Coefficient of glucose variability =SD/mean x 100 (%)

    Measured: operation end

  6. Glycemic variability

    • J index=0.001 x (MBG +SD)2 mg/dL

    Measured: operation end

  7. Glycemic variability

    • Coefficient of glucose variability =SD/mean x 100 (%)

    Measured: 1 hour after surgery

  8. Glycemic variability

    • J index=0.001 x (MBG +SD)2 mg/dL

    Measured: 1 hour after surgery

Secondary outcomes (7)

  1. Insulin resistance

    Insulin resistance index = fasting glucose x fasting insulin/22.5

    Measured: Before anesthesia

  2. Insulin resistance

    serum laboratory test: glucagon

    Measured: Before anesthesia

  3. Insulin resistance

    serum laboratory test: GLP-1

    Measured: Before anesthesia

  4. Insulin resistance

    serum laboratory test: C-peptide

    Measured: Before anesthesia

  5. Insulin resistance

    serum laboratory test: free fatty acid

    Measured: Before anesthesia

  6. gastric volume

    gastric volume measured by ultrasonography.

    Measured: Before anesthesia

  7. hand grip strength

    hand grip strength measured by electronic hand dynamometer

    Measured: Before anesthesia

Timeline

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

  1. First posted9 Jul 2019
  2. Study start20 Aug 2019
  3. Primary completion7 Oct 2020
  4. Study completion15 Oct 2020

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
Prevention
Allocation
Randomised
Intervention model
Parallel groups
Masking
Double blind
Who is masked
Investigator, Outcomes assessor
Enrolment
50 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT04013594
Sponsor's protocol ID
4-2019-0428
Status last verified
May 2021
First submitted
26 Jun 2019
Last updated
25 May 2021
Results posted
No
Data monitoring committee
Yes
FDA-regulated drug
No
FDA-regulated device
No

Publications

  • 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

  • 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

  • Lee B, Kim SY, Cho BW, Suh S, Park KK, Choi YS. Preoperative Carbohydrate Drink Intake Increases Glycemic Variability in Patients with Type 2 Diabetes Mellitus in Total Joint Arthroplasty: A Prospective Randomized Trial. World J Surg. 2022 Apr;46(4):791-799. doi: 10.1007/s00268-021-06437-1. Epub 2022 Jan 10.

    PubMed 35006328

Questions about this trial

What is this clinical trial studying?

A study testing carbohydrate group in people with Diabetes, run by Yonsei University at 1 site in South Korea.

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 1 inclusion and 6 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 25 May 2021. 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 South Korea. 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. 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?

Glycemic variability (time frame: Before anesthesia). The study lists 8 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 NCT04013594, which also lists 3 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 25 May 2021.

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