Diabetes Mellitus, Type 2NCT02845557

Glucose Homeostasis and Incretin Effect T2DM in the Youth- a Study of the Malaysian Population

An observational study of Diabetes Mellitus, Type 2, run by RCSI & UCD Malaysia Campus at 1 site in Malaysia.

Completed

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

Official record

Search all trials

Trial summary

Who is it for?: Ages 10 to 25 yearsHealthy volunteers can take part
Conditions the study is for: Diabetes Mellitus, Type 2
What is being tested?: OGTT and IVGTT tests
Type of treatment: Injection or infusion
How many people: 48 participants
Where: 1 siteMalaysia
Study dates: Feb 2013to Dec 2014
Phase: Observational
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 10 to 25 years
All sexes
Healthy volunteers accepted
Child, Adult

Study population: 30 youths with type 2 diabetes with 18 gender- and age-matched healthy controls

Who may be able to join

Youth with T2DM diagnosed at less than 25 years old
The diagnosis of T2DM established based on the American Diabetes Association criteria for diabetes and absence of GAD antibodies and islet cell antibodies (ICAs).

Who cannot join

Subjects with Type 1 Diabetes or secondary Diabetes
Patients on medication that may impair glucose metabolism (e.g., steroids)
Pregnancy

Trial locations and contacts

1 site in 1 country.

Malaysia1 site

Penang Medical College
George Town, 11450

Other trials in Malaysia

About this study

Official title: Glucose Homeostasis, Incretin Effect and Cardiovascular Risk Burden in T2DM in the Youth- a Study of the Malaysian Population

Early onset type 2 diabetes mellitus among adolescents/youth (YT2DM) is a rising phenomenon. The pathophysiology has been studied primarily on non-Asian populations while literature on incretin effect is scarce. The investigators evaluated insulin sensitivity, beta-cell function, incretin hormones and their effect in YT2DM from a multiethnic Malaysian population. The characterization of this population may enable us to better tailor their antidiabetic care.

Read the detailed description

The prevalence of Type 2 Diabetes Mellitus (T2DM) in the youth is increasing. Until 10 years ago in USA, T2DM accounted for less than 3% of all cases of new onset diabetes in adolescents. More recent data suggest up to 45% of cases are attributed to it.
The prevalence of Diabetes Mellitus in Malaysia has risen from 11.6% to 15.2% over the last 5 years according to the National Health and Morbidity Survey in 2011. Among the population age 20-24 years old, the prevalence of diabetes has risen also from 2.0% to 4.9%. Of greater concern still is 90% of these young diabetes were previously undiagnosed, thus raising the possibility that these were predominantly T2DM. The report from the Malaysian DiCare registry (2006-2007) shows that T2DM accounted for 17.6% of diabetes in adolescents. In a more recent audit of diabetes clinic in Penang General Hospital in 2012, 56.7% of patients under age of 20 have clinical T2DM (data yet unpublished). The marked difference in proportion of young T2DM in both audits may be contributed by possible under-reporting in the first audit but raise the possibility also of rising incidence of young T2DM in Malaysia.
This rising prevalence of T2DM in the youth has significant public health challenge. Studies in young adults have suggested that the development and progression of clinical complications might be especially rapid when the onset of T2DM is early. This, coupled with longer lifetime exposure to diabetes, raises the possibility of a serious public health challenge in the next few decades. Detailed understanding of the pathophysiology and complications burden among this population is therefore crucial to the development of appropriate management plan.
Studies of youth onset T2DM suggest that it is driven by a combination of insulin resistance and beta cell dysfunction, and hyperglycemia does not develop until the beta cell fails to compensate appropriately to the peripheral insulin resistance state. However, these studies are predominantly done among the western populations and mainly in the Black and Hispanic ethnic groups. There are reasons to believe that pathophysiology may be different in different populations. The ability of the beta cell to secrete sufficient insulin to adequately respond to the peripheral insulin resistance state is influenced by genetic and environmental factors. Degree of insulin resistance appears to vary among different population studies. There is currently a paucity of literature with regards to pathophysiology underpinning T2DM among the Malaysian youth.
The knowledge that incretin effect is severely reduced in patients with adult onset T2DM has been used to good pharmacotherapeutic effect in the patients. However, the incretin effect is less well studied among T2DM in the youth and understanding in this area will be helpful in guiding the use of incretin hormone for treatment of youth onset T2DM.

Conditions: Diabetes Mellitus, Type 2
Being tested: OGTT and IVGTT tests
Keywords: Youth, Type 2 Diabetes, glucose homeostasis, incretin effect
Medical subject headings: Diabetes Mellitus, Type 2

What participants receive

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

OGTT and IVGTT testsOther

Study groups in NCT02845557
Study group	Role	What they receive
Control subjects without diabetes		(i) 2-hour 75g OGTT with sampling of glucose, insulin, C-peptide and GLP-1 hormone, with sampling at fasting (time zero) and 30, 60, 90, 120 min after the glucose load. (ii) 1-hour IVGTT, with sampling at time 10 and 1 min, after which glucose (300 mg/kg body weight) infused in a contralateral vein within 30 s, starting at time zero. Blood further sampled for glucose, insulin and C-Peptide with sampling schedule: 3, 5, 6, 8, 10, 15, 20, 25,30 ,40 ,50 ,60 min; (iii) computed tomography scan, (CT) for abdominal subcutaneous and visceral fat quantification. Receives: Other: OGTT and IVGTT tests
Subjects with type 2 diabetes		(i) 2-hour 75g OGTT with sampling of glucose, insulin, C-peptide and GLP-1 hormone, with sampling at fasting (time zero) and 30, 60, 90, 120 min after the glucose load. (ii) 1-hour IVGTT, with sampling at time 10 and 1 min, after which glucose (300 mg/kg body weight) infused in a contralateral vein within 30 s, starting at time zero. Blood further sampled for glucose, insulin and C-Peptide with sampling schedule: 3, 5, 6, 8, 10, 15, 20, 25,30 ,40 ,50 ,60 min; (iii) computed tomography scan, (CT) for abdominal subcutaneous and visceral fat quantification. Receives: Other: OGTT and IVGTT tests

What is being measured

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

Quantitative Insulin Sensitivity Check Index (QUICKI)
This is a cross sectional study where the outcome was measured whenever the test was conducted.
Measured: 1 year
Oral Glucose Insulin Sensitivity Index (OGIS)
This is a cross sectional study where the outcome was measured whenever the test was conducted.
Measured: 1 year
Early phase insulin response during OGTT was calculated for the first 30 minutes
This is a cross sectional study where the outcome was measured whenever the test was conducted.
Measured: 1 year
Area under the curve for incretin hormone
This is a cross sectional study where the outcome was measured whenever the test was conducted.
Measured: 1 year

Secondary outcomes (1)

Incretin effect
It is estimated by relating the differences in beta cell responses from C peptide between stimulation with oral and intravenous glucose. The incretin effect is estimated by the formula 100 ×(BCOG BCIV)/BCOG).
Measured: 1 year

Timeline

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

Feb 2013Dec 2014

First posted27 Jul 2016 (estimated)
Study startFeb 2013
Primary completionDec 2014
Study completionDec 2014

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
Publications (23)Papers the sponsor has linked to this study.
Other trials for Diabetes Mellitus, Type 2Studies of the same condition, open and under way.
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: Observational
Observational model: Case-control
Time perspective: Cross-sectional
Enrolment: 48 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT02845557
Sponsor's protocol ID: NMRR-12-1042-13254
Status last verified: Jul 2016
First submitted: 11 Jul 2016
Last updated: 27 Jul 2016
Results posted: No
Data monitoring committee: No
Individual data sharing: Undecided

Publications

Wadwa RP, Urbina EM, Anderson AM, Hamman RF, Dolan LM, Rodriguez BL, Daniels SR, Dabelea D; SEARCH Study Group. Measures of arterial stiffness in youth with type 1 and type 2 diabetes: the SEARCH for diabetes in youth study. Diabetes Care. 2010 Apr;33(4):881-6. doi: 10.2337/dc09-0747. Epub 2010 Jan 12.
PubMed 20067960
Malloy J, Capparelli E, Gottschalk M, Guan X, Kothare P, Fineman M. Pharmacology and tolerability of a single dose of exenatide in adolescent patients with type 2 diabetes mellitus being treated with metformin: a randomized, placebo-controlled, single-blind, dose-escalation, crossover study. Clin Ther. 2009 Apr;31(4):806-15. doi: 10.1016/j.clinthera.2009.04.005.
PubMed 19446153
Rosenbloom AL, Silverstein JH, Amemiya S, Zeitler P, Klingensmith GJ. Type 2 diabetes in children and adolescents. Pediatr Diabetes. 2009 Sep;10 Suppl 12:17-32. doi: 10.1111/j.1399-5448.2009.00584.x. No abstract available.
PubMed 19754615
D'Adamo E, Caprio S. Type 2 diabetes in youth: epidemiology and pathophysiology. Diabetes Care. 2011 May;34 Suppl 2(Suppl 2):S161-5. doi: 10.2337/dc11-s212. No abstract available.
PubMed 21525449
Pinhas-Hamiel O, Zeitler P. Acute and chronic complications of type 2 diabetes mellitus in children and adolescents. Lancet. 2007 May 26;369(9575):1823-1831. doi: 10.1016/S0140-6736(07)60821-6.
PubMed 17531891
Maahs DM, Snively BM, Bell RA, Dolan L, Hirsch I, Imperatore G, Linder B, Marcovina SM, Mayer-Davis EJ, Pettitt DJ, Rodriguez BL, Dabelea D. Higher prevalence of elevated albumin excretion in youth with type 2 than type 1 diabetes: the SEARCH for Diabetes in Youth study. Diabetes Care. 2007 Oct;30(10):2593-8. doi: 10.2337/dc07-0450. Epub 2007 Jul 13.
PubMed 17630264
Hillier TA, Pedula KL. Complications in young adults with early-onset type 2 diabetes: losing the relative protection of youth. Diabetes Care. 2003 Nov;26(11):2999-3005. doi: 10.2337/diacare.26.11.2999.
PubMed 14578230
Gungor N, Bacha F, Saad R, Janosky J, Arslanian S. Youth type 2 diabetes: insulin resistance, beta-cell failure, or both? Diabetes Care. 2005 Mar;28(3):638-44. doi: 10.2337/diacare.28.3.638.
PubMed 15735201
Umpaichitra V, Bastian W, Taha D, Banerji MA, AvRuskin TW, Castells S. C-peptide and glucagon profiles in minority children with type 2 diabetes mellitus. J Clin Endocrinol Metab. 2001 Apr;86(4):1605-9. doi: 10.1210/jcem.86.4.7415.
PubMed 11297591
Kobayashi K, Amemiya S, Higashida K, Ishihara T, Sawanobori E, Kobayashi K, Mochizuki M, Kikuchi N, Tokuyama K, Nakazawa S. Pathogenic factors of glucose intolerance in obese Japanese adolescents with type 2 diabetes. Metabolism. 2000 Feb;49(2):186-91. doi: 10.1016/s0026-0495(00)91221-6.
PubMed 10690942
Musso G, Gambino R, Pacini G, De Michieli F, Cassader M. Prolonged saturated fat-induced, glucose-dependent insulinotropic polypeptide elevation is associated with adipokine imbalance and liver injury in nonalcoholic steatohepatitis: dysregulated enteroadipocyte axis as a novel feature of fatty liver. Am J Clin Nutr. 2009 Feb;89(2):558-67. doi: 10.3945/ajcn.2008.26720. Epub 2009 Jan 13.
PubMed 19141695
Pacini G, Tura A, Winhofer Y, Kautzky-Willer A. Incretin Effect in Women with Former Gestational Diabetes within a Short Period after Delivery. Int J Endocrinol. 2012;2012:247392. doi: 10.1155/2012/247392. Epub 2012 Apr 19.
PubMed 22577378
Danadian K, Balasekaran G, Lewy V, Meza MP, Robertson R, Arslanian SA. Insulin sensitivity in African-American children with and without family history of type 2 diabetes. Diabetes Care. 1999 Aug;22(8):1325-9. doi: 10.2337/diacare.22.8.1325.
PubMed 10480778
Kvist H, Chowdhury B, Grangard U, Tylen U, Sjostrom L. Total and visceral adipose-tissue volumes derived from measurements with computed tomography in adult men and women: predictive equations. Am J Clin Nutr. 1988 Dec;48(6):1351-61. doi: 10.1093/ajcn/48.6.1351.
PubMed 3202084
McQuaid S, O'Gorman DJ, Yousif O, Yeow TP, Rahman Y, Gasparro D, Pacini G, Nolan JJ. Early-onset insulin-resistant diabetes in obese Caucasians has features of typical type 2 diabetes, but 3 decades earlier. Diabetes Care. 2005 May;28(5):1216-8. doi: 10.2337/diacare.28.5.1216. No abstract available.
PubMed 15855595

Want to know more?

The sponsor has not listed a contact. The official record may have more details.

Talk to your doctor first and take this page with you. Only the study team can confirm whether you can join.

Questions to ask the study team

What is the study trying to find out?
What would I need to do, and how often would I visit?
Could I receive a placebo instead of the treatment?
What are the possible risks and benefits for me?
Will it cost me anything? Are travel or time paid for?
Can I keep seeing my own doctor during the study?
What happens when the study ends?

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All Diabetes Mellitus, Type 2 trials

Study at a glance

From the registry record, last updated by the sponsor on 27 Jul 2016. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: Glucose Homeostasis, Incretin Effect and Cardiovascular Risk Burden in T2DM in the Youth- a Study of the Malaysian Population
ClinicalTrials.gov ID: NCT02845557
Acronym / sponsor ID: NMRR-12-1042-13254
Conditions: Diabetes Mellitus, Type 2
Keywords: Youth, Type 2 Diabetes, glucose homeostasis, incretin effect
Study type: Observational
Recruitment status: Completed
Enrolment: 48 participants (actual)
Lead sponsor: RCSI & UCD Malaysia CampusUniversity, hospital or other
Collaborators: Sarawak General Hospital, Putrajaya Hospital, Malaysia, Penang Hospital, Malaysia, The National Research Council, Italy, University of Copenhagen, Institute for Medical Research, Malaysia, Seberang Jaya Clinical Research Centre
Study start: Feb 2013
Primary completion: Dec 2014 (actual)
Study completion: Dec 2014 (actual)
First posted: 27 Jul 2016 (estimated)
Results: Not posted in the source record

Clinical summary

The research question as the sponsor registered it. This describes what the study plans to test, not what it found.

Detailed description

The prevalence of Type 2 Diabetes Mellitus (T2DM) in the youth is increasing. Until 10 years ago in USA, T2DM accounted for less than 3% of all cases of new onset diabetes in adolescents. More recent data suggest up to 45% of cases are attributed to it.
The prevalence of Diabetes Mellitus in Malaysia has risen from 11.6% to 15.2% over the last 5 years according to the National Health and Morbidity Survey in 2011. Among the population age 20-24 years old, the prevalence of diabetes has risen also from 2.0% to 4.9%. Of greater concern still is 90% of these young diabetes were previously undiagnosed, thus raising the possibility that these were predominantly T2DM. The report from the Malaysian DiCare registry (2006-2007) shows that T2DM accounted for 17.6% of diabetes in adolescents. In a more recent audit of diabetes clinic in Penang General Hospital in 2012, 56.7% of patients under age of 20 have clinical T2DM (data yet unpublished). The marked difference in proportion of young T2DM in both audits may be contributed by possible under-reporting in the first audit but raise the possibility also of rising incidence of young T2DM in Malaysia.
This rising prevalence of T2DM in the youth has significant public health challenge. Studies in young adults have suggested that the development and progression of clinical complications might be especially rapid when the onset of T2DM is early. This, coupled with longer lifetime exposure to diabetes, raises the possibility of a serious public health challenge in the next few decades. Detailed understanding of the pathophysiology and complications burden among this population is therefore crucial to the development of appropriate management plan.
Studies of youth onset T2DM suggest that it is driven by a combination of insulin resistance and beta cell dysfunction, and hyperglycemia does not develop until the beta cell fails to compensate appropriately to the peripheral insulin resistance state. However, these studies are predominantly done among the western populations and mainly in the Black and Hispanic ethnic groups. There are reasons to believe that pathophysiology may be different in different populations. The ability of the beta cell to secrete sufficient insulin to adequately respond to the peripheral insulin resistance state is influenced by genetic and environmental factors. Degree of insulin resistance appears to vary among different population studies. There is currently a paucity of literature with regards to pathophysiology underpinning T2DM among the Malaysian youth.
The knowledge that incretin effect is severely reduced in patients with adult onset T2DM has been used to good pharmacotherapeutic effect in the patients. However, the incretin effect is less well studied among T2DM in the youth and understanding in this area will be helpful in guiding the use of incretin hormone for treatment of youth onset T2DM.

Study design

Observational model: Case-control
Time perspective: Cross-sectional
Number of arms: 2

Arm	Type	Receives
Control subjects without diabetes	–	Other: OGTT and IVGTT tests(i) 2-hour 75g OGTT with sampling of glucose, insulin, C-peptide and GLP-1 hormone, with sampling at fasting (time zero) and 30, 60, 90, 120 min after the glucose load. (ii) 1-hour IVGTT, with sampling at time 10 and 1 min, after which glucose (300 mg/kg body weight) infused in a contralateral vein within 30 s, starting at time zero. Blood further sampled for glucose, insulin and C-Peptide with sampling schedule: 3, 5, 6, 8, 10, 15, 20, 25,30 ,40 ,50 ,60 min; (iii) computed tomography scan, (CT) for abdominal subcutaneous and visceral fat quantification.
Subjects with type 2 diabetes	–	Other: OGTT and IVGTT tests(i) 2-hour 75g OGTT with sampling of glucose, insulin, C-peptide and GLP-1 hormone, with sampling at fasting (time zero) and 30, 60, 90, 120 min after the glucose load. (ii) 1-hour IVGTT, with sampling at time 10 and 1 min, after which glucose (300 mg/kg body weight) infused in a contralateral vein within 30 s, starting at time zero. Blood further sampled for glucose, insulin and C-Peptide with sampling schedule: 3, 5, 6, 8, 10, 15, 20, 25,30 ,40 ,50 ,60 min; (iii) computed tomography scan, (CT) for abdominal subcutaneous and visceral fat quantification.

Who may qualify

Ages: 10 to 25 years
Sex: All
Healthy volunteers: Accepted
Age groups: Child, Adult
Study population: 30 youths with type 2 diabetes with 18 gender- and age-matched healthy controls

Key inclusion criteria (2 listed)

Youth with T2DM diagnosed at less than 25 years old
The diagnosis of T2DM established based on the American Diabetes Association criteria for diabetes and absence of GAD antibodies and islet cell antibodies (ICAs).

Key exclusion criteria (3 listed)

Subjects with Type 1 Diabetes or secondary Diabetes
Patients on medication that may impair glucose metabolism (e.g., steroids)
Pregnancy

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
OGTT and IVGTT tests	Other	Control subjects without diabetes, Subjects with type 2 diabetes

Primary outcome

Quantitative Insulin Sensitivity Check Index (QUICKI)
Time frame: 1 year
This is a cross sectional study where the outcome was measured whenever the test was conducted.
Oral Glucose Insulin Sensitivity Index (OGIS)
Time frame: 1 year
This is a cross sectional study where the outcome was measured whenever the test was conducted.
Early phase insulin response during OGTT was calculated for the first 30 minutes
Time frame: 1 year
This is a cross sectional study where the outcome was measured whenever the test was conducted.
Area under the curve for incretin hormone
Time frame: 1 year
This is a cross sectional study where the outcome was measured whenever the test was conducted.

1 secondary outcome

Incretin effect
Time frame: 1 year

Results and safety

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

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 27 Jul 2016.
Background: PubMed 20067960Wadwa RP, Urbina EM, Anderson AM, Hamman RF, Dolan LM, Rodriguez BL, Daniels SR, Dabelea D; SEARCH Study Group. Measures of arterial stiffness in youth with type 1 and type 2 diabetes: the SEARCH for diabetes in youth study. Diabetes Care. 2010 Apr;33(4):881-6. doi: 10.2337/dc09-0747. Epub 2010 Jan 12.
Background: PubMed 19446153Malloy J, Capparelli E, Gottschalk M, Guan X, Kothare P, Fineman M. Pharmacology and tolerability of a single dose of exenatide in adolescent patients with type 2 diabetes mellitus being treated with metformin: a randomized, placebo-controlled, single-blind, dose-escalation, crossover study. Clin Ther. 2009 Apr;31(4):806-15. doi: 10.1016/j.clinthera.2009.04.005.
Results publication: PubMed 19754615Rosenbloom AL, Silverstein JH, Amemiya S, Zeitler P, Klingensmith GJ. Type 2 diabetes in children and adolescents. Pediatr Diabetes. 2009 Sep;10 Suppl 12:17-32. doi: 10.1111/j.1399-5448.2009.00584.x. No abstract available.
Results publication: PubMed 21525449D'Adamo E, Caprio S. Type 2 diabetes in youth: epidemiology and pathophysiology. Diabetes Care. 2011 May;34 Suppl 2(Suppl 2):S161-5. doi: 10.2337/dc11-s212. No abstract available.
Results publication: PubMed 17531891Pinhas-Hamiel O, Zeitler P. Acute and chronic complications of type 2 diabetes mellitus in children and adolescents. Lancet. 2007 May 26;369(9575):1823-1831. doi: 10.1016/S0140-6736(07)60821-6.
Results publication: PubMed 17630264Maahs DM, Snively BM, Bell RA, Dolan L, Hirsch I, Imperatore G, Linder B, Marcovina SM, Mayer-Davis EJ, Pettitt DJ, Rodriguez BL, Dabelea D. Higher prevalence of elevated albumin excretion in youth with type 2 than type 1 diabetes: the SEARCH for Diabetes in Youth study. Diabetes Care. 2007 Oct;30(10):2593-8. doi: 10.2337/dc07-0450. Epub 2007 Jul 13.
Results publication: PubMed 14578230Hillier TA, Pedula KL. Complications in young adults with early-onset type 2 diabetes: losing the relative protection of youth. Diabetes Care. 2003 Nov;26(11):2999-3005. doi: 10.2337/diacare.26.11.2999.
Results publication: PubMed 15735201Gungor N, Bacha F, Saad R, Janosky J, Arslanian S. Youth type 2 diabetes: insulin resistance, beta-cell failure, or both? Diabetes Care. 2005 Mar;28(3):638-44. doi: 10.2337/diacare.28.3.638.
Results publication: PubMed 11297591Umpaichitra V, Bastian W, Taha D, Banerji MA, AvRuskin TW, Castells S. C-peptide and glucagon profiles in minority children with type 2 diabetes mellitus. J Clin Endocrinol Metab. 2001 Apr;86(4):1605-9. doi: 10.1210/jcem.86.4.7415.
Results publication: PubMed 10690942Kobayashi K, Amemiya S, Higashida K, Ishihara T, Sawanobori E, Kobayashi K, Mochizuki M, Kikuchi N, Tokuyama K, Nakazawa S. Pathogenic factors of glucose intolerance in obese Japanese adolescents with type 2 diabetes. Metabolism. 2000 Feb;49(2):186-91. doi: 10.1016/s0026-0495(00)91221-6.
Results publication: PubMed 19141695Musso G, Gambino R, Pacini G, De Michieli F, Cassader M. Prolonged saturated fat-induced, glucose-dependent insulinotropic polypeptide elevation is associated with adipokine imbalance and liver injury in nonalcoholic steatohepatitis: dysregulated enteroadipocyte axis as a novel feature of fatty liver. Am J Clin Nutr. 2009 Feb;89(2):558-67. doi: 10.3945/ajcn.2008.26720. Epub 2009 Jan 13.
Results publication: PubMed 22577378Pacini G, Tura A, Winhofer Y, Kautzky-Willer A. Incretin Effect in Women with Former Gestational Diabetes within a Short Period after Delivery. Int J Endocrinol. 2012;2012:247392. doi: 10.1155/2012/247392. Epub 2012 Apr 19.
Individual participant dataSharing planned: Undecided

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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.

The record lists no contact. Use the official record to reach the sponsor.

1 site in 1 country: see every site and its status.

Questions about this trial

What is this clinical trial studying?

An observational study of Diabetes Mellitus, Type 2, run by RCSI & UCD Malaysia Campus at 1 site in Malaysia.

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 2 inclusion and 3 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 27 Jul 2016. 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 Malaysia. 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?

Quantitative Insulin Sensitivity Check Index (QUICKI) (time frame: 1 year). The study lists 4 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 NCT02845557, which also lists 23 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 27 Jul 2016.