Insulin SensitivityPhase 4NCT01774084
Insulin Sensitivity and Beta Cell Function After Carbohydrate Loading in Hip Replacement Surgery
A Phase 4 study testing Experimental: PreOp, NutriciaNordica AB in people with Insulin Sensitivity, run by Karolinska Institutet at 2 sites in Sweden.
Trial summary
The purpose of this study is to determine whether preload of carbohydrate or water before elective hip replacement improve insulin sensitivity and or beta cell function in human. Read more about this study
- Who is it for?
- Ages 18 to 80 yearsHealthy volunteers can take part
- Conditions the study is for
- Insulin Sensitivity
- What is being tested?
- Experimental: PreOp, NutriciaNordica AB
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 23 participants
- Where
- 2 sitesSweden
- Study dates
- Jan 2012to Mar 2013
- Phase
- Phase 4
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
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 to 80 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Elective hip replacement
Who cannot join
- Known diabetes mellitus
- Kidney failure (creatinine clearance <40 ml/min
- Liver failure (aspartate and alanine aminotransferases x 2 above reference)
- Hb <110 g/l
- Ongoing severe bacterial or viral infection
- Malignancies
- Psychiatric disease
Trial locations and contacts
2 sites in 1 country.
Sweden2 sites
Södertälje hospital
Södertälje, Södertälje, 15286
Södersjukhuset AB
Stockholm, Sweden, 116 48
About this study
Official title: Insulin Sensitivity and Beta Cell Function After Carbohydrate Loading in Hip Replacement Surgery: A Randomised Doubled-blinded Control Study
The purpose of this study is to determine whether preload of carbohydrate or water before elective hip replacement improve insulin sensitivity and or beta cell function in human.
- Conditions
- Insulin Sensitivity
- Being tested
- Experimental: PreOp, NutriciaNordica AB, Placebo Comparator: Water
- Keywords
- Insulin sensitivity, Beta cell function, Carbohydrate preload, Elective hip replacement, Double-blind randomized control study
- Medical subject headings
- Insulin Resistance
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Experimental: PreOp, NutriciaNordica ABDietary supplement
Also called PreOp, serial number 27 62 95, NutriciaNordica AB
Placebo Comparator: WaterDietary supplement
| Study group | Role | What they receive |
|---|---|---|
| PreOp, NutriciaNordica AB | Active comparator | PreOp: 50 kcal/100 mL in the form of maltodextrin and fructose. One bottle of 800 ml to be ingested at bedtime, and at midnight by the latest, and another bottle with 400 ml approximately 2 hours before surgery started. Receives: Dietary Supplement: Experimental: PreOp, NutriciaNordica AB |
| Water | Placebo comparator | Water: One bottle of 800 ml to be ingested at bedtime, and at midnight by the latest, and another bottle with 400 ml approximately 2 hours before surgery started. Receives: Dietary Supplement: Placebo Comparator: Water |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in Insulin Sensitivity
Insulin sensitivity is measured by euglycemic hyperinsulinemic clamp
Measured: Morning before surgery and up to two days after surgery
Secondary outcomes (1)
Change in Beta Cell Function
Beta cell function is measured with intravenous glucose tolerance test (IVGTT)
Measured: Morning before surgery and up to two days after surgery
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted23 Jan 2013 (estimated)
- Study startJan 2012
- Primary completionFeb 2013
- Study completionMar 2013
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Insulin SensitivityStudies of the same condition, open and under way.
- More trials run by Karolinska InstitutetThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
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 4
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 23 participants (actual)
Sponsor and investigators
- Lead sponsor
- Karolinska Institutet
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Thomas Nystrom, Karolinska Institutet
- Investigators
- Thomas Nyström, MD, Principal investigator, Karolinska Institutet
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01774084
- Sponsor's protocol ID
- 2011/3:6
- Status last verified
- Jun 2014
- First submitted
- 20 Jan 2013
- Last updated
- 5 Jun 2014
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- Yes
Publications
Ljunggren S, Hahn RG, Nystrom T. Insulin sensitivity and beta-cell function after carbohydrate oral loading in hip replacement surgery: a double-blind, randomised controlled clinical trial. Clin Nutr. 2014 Jun;33(3):392-8. doi: 10.1016/j.clnu.2013.08.003. Epub 2013 Aug 15.
PubMed 24007934
Study at a glance
From the registry record, last updated by the sponsor on 5 Jun 2014. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Insulin Sensitivity and Beta Cell Function After Carbohydrate Loading in Hip Replacement Surgery: A Randomised Doubled-blinded Control Study
- ClinicalTrials.gov ID
- NCT01774084
- Acronym / sponsor ID
- 2011/3:6
- Conditions
- Insulin Sensitivity
- Keywords
- Insulin sensitivity, Beta cell function, Carbohydrate preload, Elective hip replacement, Double-blind randomized control study
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 23 participants (actual)
- Lead sponsor
- Karolinska InstitutetUniversity, hospital or other
- Study start
- Jan 2012
- Primary completion
- Feb 2013 (actual)
- Study completion
- Mar 2013 (actual)
- First posted
- 23 Jan 2013 (estimated)
- Results
- Posted 5 Jun 2014
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The purpose of this study is to determine whether preload of carbohydrate or water before elective hip replacement improve insulin sensitivity and or beta cell function in human.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| PreOp, NutriciaNordica AB | Active comparator | Dietary Supplement: Experimental: PreOp, NutriciaNordica ABPreOp: 50 kcal/100 mL in the form of maltodextrin and fructose. One bottle of 800 ml to be ingested at bedtime, and at midnight by the latest, and another bottle with 400 ml approximately 2 hours before surgery started. |
| Water | Placebo comparator | Dietary Supplement: Placebo Comparator: WaterWater: One bottle of 800 ml to be ingested at bedtime, and at midnight by the latest, and another bottle with 400 ml approximately 2 hours before surgery started. |
Who may qualify
- Ages
- 18 to 80 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- Elective hip replacement
Key exclusion criteria (7 listed)
- Known diabetes mellitus
- Kidney failure (creatinine clearance <40 ml/min
- Liver failure (aspartate and alanine aminotransferases x 2 above reference)
- Hb <110 g/l
- Ongoing severe bacterial or viral infection
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Experimental: PreOp, NutriciaNordica ABAlso: PreOp, serial number 27 62 95, NutriciaNordica AB | Dietary supplement | PreOp, NutriciaNordica AB |
| Placebo Comparator: Water | Dietary supplement | Water |
Primary outcome
Change in Insulin Sensitivity
Time frame: Morning before surgery and up to two days after surgery
Insulin sensitivity is measured by euglycemic hyperinsulinemic clamp
1 secondary outcome
Change in Beta Cell Function
Time frame: Morning before surgery and up to two days after surgery
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 5 Jun 2014.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Derived from this study: PubMed 24007934Ljunggren S, Hahn RG, Nystrom T. Insulin sensitivity and beta-cell function after carbohydrate oral loading in hip replacement surgery: a double-blind, randomised controlled clinical trial. Clin Nutr. 2014 Jun;33(3):392-8. doi: 10.1016/j.clnu.2013.08.003. Epub 2013 Aug 15.
- Related InfoLink provided by the sponsor.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Thomas Nyström, MD principal investigator
Karolinska Institutet
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing Experimental: PreOp, NutriciaNordica AB in people with Insulin Sensitivity, run by Karolinska Institutet at 2 sites in Sweden.
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 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 5 Jun 2014. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in Sweden. 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.
What does this phase mean?
Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Yes. Results are posted in the registry (first posted 5 Jun 2014). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
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?
Change in Insulin Sensitivity (time frame: Morning before surgery and up to two days after surgery). 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 NCT01774084, which also lists 1 linked publication.
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 5 Jun 2014.