A Phase 4 interventional study of Acarbose 100 MG and Exenatide in PCOS and Impaired Glucose Tolerance, sponsored by RenJi Hospital. Status unknown at 1 site in China. Open to female participants aged 18 Years to 40 Years. Per ClinicalTrials.gov, last updated 2017-12-26.
Sponsored by RenJi Hospital · Phase 4, Interventional, and Treatment
Help build ClinicalTrials.gg — short surveys, remote interviews or testing, in your language. Take part →
Among 13 studies testing exenatide in Glucose Intolerance — none open to participants now, none under way, none of them phase 3. Exenatide · Glucose Intolerance.
Among the 13 studies testing exenatide in Glucose Intolerance, this one has the largest planned enrollment, is the only one that started in 2018, is one of 8 in phase 4, and was the 12th registered.
793 studies on the registry are indexed under Glucose Intolerance; 115 are open to participants now.
Browse Glucose Intolerance studies →None of the 13 studies testing exenatide in Glucose Intolerance is open now. The open studies under Glucose Intolerance, anywhere →
Exenatide: first FDA approval 2005 (BYETTA), first EMA approval 2006. What it is approved for, and how studies give it, is on its page →
Of the 70 Glucose Intolerance studies recruiting now, 14 (20%) set no upper age limit and 51 (73%) stop at 75 or younger; 10 take children under 18; 33 take healthy volunteers.
This study: 18 Years to 40 Years · female · no healthy volunteers.
The full table on the hub →This tab as a report to print or save as PDF → With an account.
13 studies; the count open now beside each. This study's row is marked.
A study in two phases is counted once above. Listed by phase, each with its combined phases: Phase 1 2 · Phase 2 3 · Phase 4 8
First in 2006; this study’s year is marked. 1 started in 2018.
By drug class, each counting the studies that test any of its medicines:
This study's planned enrollment of 160 is above the median of 56 across 661 interventional studies indexed under Glucose Intolerance.
Median enrollment 43 across the 13 interventional studies. Of the 11 that completed or were terminated, 9 (82%) have results posted.
This tab as a report to print or save as PDF → With an account.
None of the 13 has an industry lead sponsor. The 10 most frequent:
RenJi Hospital is the lead sponsor of 550 studies on the registry; 247 are open to participants now.
RenJi Hospital has 1 study filed under Glucose Intolerance — fewer than ten, so there is no comparison to draw.
None of the studies under way reaches primary completion within a year.
Among the 13 studies testing exenatide in Glucose Intolerance, from their registry updates:
Nothing recorded among them since 2026-09-25.
This tab as a report to print or save as PDF → With an account.
To investigate whether intensive metabolic intervention of PCOS women before pregnancy can improve pregnancy outcome.Besides, the investigators aim to investigate the best therapy strategy of metabolic intervention before pregnancy.The investigators plan to recruit PCOS women at childbearing age. By using acarbose, GLP-1 analogue, berberin et al. the investigators will intervent the participants' metabolic statues for 3 months before pregnancy and to compare outcome in each group.
To investigate whether intensive metabolic intervention of PCOS women before pregnancy can improve pregnancy outcome.Besides, the investigators aim to investigate the best therapy strategy of metabolic intervention before pregnancy.The investigators plan to recruit PCOS women with IGR / DM not effective of metformin treatment at childbearing age. By using acarbose, GLP-1 analogue, berberin et al. the investigators will intervent the participants' metabolic statues for 3 months before pregnancy and to compare outcome in each group.
Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.
Exclusion Criteria:
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Anti-inflammatory medicines such as prednisone, prednisolone and dexamethasone — not the anabolic steroids used for muscle.
Studies differ in what they allow: check which steroid medicines, routes (tablets, injections, creams, inhalers, eye drops) and doses this study accepts.
Ways of preventing pregnancy. “Highly effective” methods fail less than 1% of the time a year when used correctly — for example an IUD or an implant.
Criteria usually say which methods count and how long to keep using them after the last dose, sometimes for male participants too. Some studies accept a partner’s vasectomy if it was confirmed successful and that person is the participant’s only sexual partner.
Corticosteroids (steroids)
Anti-inflammatory medicines such as prednisone, prednisolone and dexamethasone — not the anabolic steroids used for muscle.
Studies differ in what they allow: check which steroid medicines, routes (tablets, injections, creams, inhalers, eye drops) and doses this study accepts.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Contraception
Ways of preventing pregnancy. “Highly effective” methods fail less than 1% of the time a year when used correctly — for example an IUD or an implant.
Criteria usually say which methods count and how long to keep using them after the last dose, sometimes for male participants too. Some studies accept a partner’s vasectomy if it was confirmed successful and that person is the participant’s only sexual partner.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
metformin(1000-1500mg/d) treated for 6 months, reverse to normal glucose tolerance
Drug: Metformin
metformin(1000-1500mg/d) treated for 6 months, can not reverse to normal glucose tolerance, then treat with acarbose (100mg tid ) for 3 months
Drug: Acarbose 100 MG
metformin(1000-1500mg/d) treated for 6 months, can not reverse to normal glucose tolerance, then treat with Exenatide 10μg/bid ) for 3 months
Drug: Exenatide
metformin(1000-1500mg/d) treated for 6 months, can not reverse to normal glucose tolerance, then treat with Orlistat(0.12mg/tid ) for 3 months
Drug: Orlistat
for metformin uneffective subjects, using acarbose for 3 months
Also known as: Acarbose
for metformin uneffective subjects, using Exenatide for 3 months
for metformin uneffective subjects, using Orlistatfor 3 months
metformin effective subjects,act as control group
Also known as: METF
Improvement of pregnant rate after intensive metabolic intervention
To compare the pregnant rate of four groups after treatment
Time frame: up to 24 weeks
Improvement of obsorbtion rate after intensive metabolic intervention
To compare the obsorbtion rate of four groups after treatment
Time frame: up to 24 weeks
Improvement of stillborn foetus rate after intensive metabolic intervention
To compare the stillborn foetus rate of four groups after treatment
Time frame: up to 24 weeks
Improvement of hyperandrogenism
To compare the free androgen index of three groups after treatment
Time frame: up to 24 weeks
Improvement of intravenous blood glucose from impaired glucose regulation to normal glucose regulation
To compare the intravenous blood glucose of three groups after treatment
Time frame: up to 24 weeks
Improvement of triglyceride
To compare the circulating triglyceride of three groups after treatment
Time frame: up to 24 weeks
Plan to share: No
No publications or documents are linked to this record.
Start is estimated for Jan 2018; primary completion for Dec 2018, 11 months later.
Of 15 phase 4 interventional studies under Glucose Intolerance, half reached primary completion within 40 months of starting (the median), counting those still running; a quarter within 16 and three quarters within 47. This study's planned 11 months is below that.
How these figures are worked out, and which studies are left out of them.
This study is status unknown, as verified in Dec 2017. You cannot join it, but the record below documents what was studied.
Get an email when the registry record changes — status, dates, results — or when someone posts here.
Sign in to followQuestions and observations about this study, from anyone following it. Not medical advice, and not a channel to the study team — their contact details are on the registry record.
Sign in to join the discussion. Reading takes no account; posting does. You choose a display name, and a pseudonym is the default.
Nothing here yet. If you are running this trial, taking part in it, or weighing whether to, this is the place to say so.
Studies of the drugs tested here: Acarbose · Exenatide · Orlistat