Increased InsulinNCT03455049
The Effect of Andrographis Paniculata to GLP-1, Fasting Insulin, Insulin 2-h Post OGTT, and HOMA-IR
A study testing Andrographis Paniculata Ext in people with Increased Insulin, run by Universitas Indonesia at 1 site in Indonesia.
Trial summary
Prevalence of type 2 diabetes have been increased, but medications had not been well, so that needed new alternatives. A new approach used in management of type 2 diabetes is incretin based therapy. Read more about this study
- Who is it for?
- Ages 18 to 60 years
- Conditions the study is for
- Increased Insulin
- What is being tested?
- Andrographis Paniculata Ext
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 73 participants
- Where
- 1 siteIndonesia
- Study dates
- 17 Oct 2017to 2 May 2018
- 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 to 60 years
- All sexes
- No healthy volunteers
- Adult
Who may be able to join
- Age 18 year old until 60 year old
- Normal glucose tolerance subject or prediabetes
- The kidney function (creatinine) and liver function (SGPT) in range normal
- Subject has signed agreement (informed consent)
Who cannot join
- Pregnant
- Feeding baby
- Subject has comorbide or chronic disease uncontrolled
- Subject has cancer
- Subject consume medication influenced blood glucose such as steroid an suplement
- Insulin dependent diabetes
Trial locations and contacts
1 site in 1 country.
Indonesia1 site
Faculty of Medicine, Universitas Indonesia
Jakarta Pusat, DKI Jakarta, 10430
About this study
Official title: The Effect of Andrographis Paniculata to GLP-1, Fasting Insulin, Insulin 2-h Post OGTT, and HOMA-IR in Normal and Prediabetes Subject
Prevalence of type 2 diabetes have been increased, but medications had not been well, so that needed new alternatives. A new approach used in management of type 2 diabetes is incretin based therapy. Incretin hormone, glucagon-like peptide 1 (GLP-1) and glucose-dependent insulinotrophic peptide (GIP), had producted in intestine due to carbohydrate intralumen. After had secreted, GLP-1 had degradated by DPP-4 enzyme till number and effect had been decreased. Decreasing of GLP-1 effect as main defect in type 2 diabetes.
Andrographis paniculata (A. paniculata) as traditional treatment had known since years ago to have hypoglycemia effect. Extract of A. paniculata consists of andrographolid and flavonoid. Based on study of Wooten et al that flavonoid has hydroxyl to stimulate insulin's production through modulated GLP-1 receptor (GLP-1 receptor ligand). So the investigators need to study about The Effect of A. paniculata Extract to GLP-1, Fasting Plasma Insulin, Insulin concentrations measured during a standardized 2-h OGTT, and HOMA-IR.
Read the detailed description
Blood's participants will be examined fasting plasma insulin and glycated albumin (from fasting blood) and insulin measured during a standardized 2-h OGTT, DPP-4 enzyme, and GLP-1 (from standardized 2-h OGTT blood). Then, complete urinalysis test. Participants will be randomized to be two groups are group have been intervenced by capsules of A. paniculata or group placebo. Each group will be explained about procedure to consume capsules A. paniculata or placebo for 14 days, storage procedures, and the way to contact the investigators if adverse event happened. The investigators will contact participants to remember the schedule to consume capsules A. paniculata, ask whether the side effects or not, and ask the result of self monitoring blood glucose every three days by glucose meter have been given.
Before day 12th, participants will be contacted to come in visit 2nd. In visit 2nd (day 15th) will be done anamneses, assessment of compliance, reporting adverse event and side effect, physical examination, fasting plasma glucose test, fasting insulin, HOMA-IR, GA and complete urinalysis. Then, will be done standardized 2-h OGTT. Two hours later, it will be done plasma glucose level, insulin, DPP-4 enzyme, and GLP-1. Participants will be explained that they will not receive capsules of A. paniculata for 7 days (day 15th till 21th). This is called wash out.
Participants will be explained about procedures to consume capsule of A. paniculata or placebo in day 22th till 35th. Before day 32th, participants will be contacted to come in visit 3rd (day 36th). In visit 3rd, will be done anamneses, assessment of compliance, reporting adverse event and side effect, physical examination, fasting plasma glucose test, fasting insulin, HOMA-IR, GA and complete urinalysis. Then, will be done standardized 2-h OGTT. Two hours later, it will be done plasma glucose level, insulin, DPP-4 enzyme, and GLP-1.
- Conditions
- Increased Insulin
- Being tested
- Andrographis Paniculata Ext
- Medical subject headings
- Hyperinsulinism
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Andrographis Paniculata ExtOther
Give the Androgaphis paniculata in prediabetes and normal subject for 14 days.
| Study group | Role | What they receive |
|---|---|---|
| Normal subject experimental | Experimental | Participants get Andrographis Paniculata Extract 550 mg, two capsules, twice a day, for 14 days. Receives: Other: Andrographis Paniculata Ext |
| Normal subject placebo | Placebo comparator | Participants get placebo consist of Lactose 98%, Mg 2%, two capsules, twice a day, for 14 days. Receives: Other: Andrographis Paniculata Ext |
| Prediabetes subject experimental | Experimental | Participants get Andrographis Paniculata Extract 550 mg, two capsules, twice a day, for 14 days. Receives: Other: Andrographis Paniculata Ext |
| Prediabetes subject placebo | Placebo comparator | Participants get placebo consist of Lactose 98%, Mg 2%, two capsules, twice a day, for 14 days. Receives: Other: Andrographis Paniculata Ext |
What is being measured
The primary outcome is the main question the study is designed to answer.
GLP-1
Index analyzes incretin effect
Measured: A measure assesing change from baseline GLP-1 at 14 days.
Secondary outcomes (7)
Fasting Insulin
Index analyzes beta-cell secretion
Measured: A measure assesing change from baseline GLP-1 at 14 days.
2h-OGTT Insulin
Index analyzes beta-cell secretion after 2h-OGTT
Measured: A measure assesing change from baseline GLP-1 at 14 days.
HOMA-IR
Index of insulin resistance
Measured: A measure assesing change from baseline GLP-1 at 14 days.
Fasting plasma glucose level
Index analyzes beta-cell function
Measured: A measure assesing change from baseline GLP-1 at 14 days.
2h-OGTT plasma glucose level
Index analyzes beta-cell function after 2h-OGTT
Measured: A measure assesing change from baseline GLP-1 at 14 days.
Dypeptidil Peptidase 4 (DPP-4) Enzyme
Index analyzes degradation of GLP-1 in Ileum
Measured: A measure assesing change from baseline GLP-1 at 14 days.
Glycated Albumin
Index analyzes plasma glucose during 2 weeks
Measured: A measure assesing change from baseline GLP-1 at 14 days.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted6 Mar 2018
- Study start17 Oct 2017
- Primary completion2 May 2018
- Study completion2 May 2018
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for Increased InsulinStudies of the same condition, open and under way.
- More trials run by Universitas IndonesiaThe 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 N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Model description
- Clinical Trials with Randomization, Double Blind, Crossover
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 73 participants (actual)
Sponsor and investigators
- Lead sponsor
- Universitas Indonesia
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Dr Tri Juli Edi Tarigan, SpPD-KEMD, Universitas Indonesia
- Investigators
- Tri Juli Edi Tarigan, MD, Principal investigator, Fakultas Kedokteran Universitas Indonesia
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03455049
- Sponsor's protocol ID
- IndonesiaU-02
- Status last verified
- Sep 2020
- First submitted
- 17 Jan 2018
- Last updated
- 14 Sep 2020
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Wedick NM, Pan A, Cassidy A, Rimm EB, Sampson L, Rosner B, Willett W, Hu FB, Sun Q, van Dam RM. Dietary flavonoid intakes and risk of type 2 diabetes in US men and women. Am J Clin Nutr. 2012 Apr;95(4):925-33. doi: 10.3945/ajcn.111.028894. Epub 2012 Feb 22.
PubMed 22357723Tarigan TJE, Purwaningsih EH, Yusra, Abdullah M, Nafrialdi, Prihartono J, Saraswati MR, Subekti I. Effects of Sambiloto (Andrographis paniculata) on GLP-1 and DPP-4 Concentrations between Normal and Prediabetic Subjects: A Crossover Study. Evid Based Complement Alternat Med. 2022 Jan 15;2022:1535703. doi: 10.1155/2022/1535703. eCollection 2022.
PubMed 35075363
Study at a glance
From the registry record, last updated by the sponsor on 14 Sep 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Effect of Andrographis Paniculata to GLP-1, Fasting Insulin, Insulin 2-h Post OGTT, and HOMA-IR in Normal and Prediabetes Subject
- ClinicalTrials.gov ID
- NCT03455049
- Acronym / sponsor ID
- IndonesiaU-02
- Conditions
- Increased Insulin
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 73 participants (actual)
- Lead sponsor
- Universitas IndonesiaUniversity, hospital or other
- Study start
- 17 Oct 2017 (actual)
- Primary completion
- 2 May 2018 (actual)
- Study completion
- 2 May 2018 (actual)
- First posted
- 6 Mar 2018 (actual)
- 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.
Prevalence of type 2 diabetes have been increased, but medications had not been well, so that needed new alternatives. A new approach used in management of type 2 diabetes is incretin based therapy. Incretin hormone, glucagon-like peptide 1 (GLP-1) and glucose-dependent insulinotrophic peptide (GIP), had producted in intestine due to carbohydrate intralumen. After had secreted, GLP-1 had degradated by DPP-4 enzyme till number and effect had been decreased. Decreasing of GLP-1 effect as main defect in type 2 diabetes.
Andrographis paniculata (A. paniculata) as traditional treatment had known since years ago to have hypoglycemia effect. Extract of A. paniculata consists of andrographolid and flavonoid. Based on study of Wooten et al that flavonoid has hydroxyl to stimulate insulin's production through modulated GLP-1 receptor (GLP-1 receptor ligand). So the investigators need to study about The Effect of A. paniculata Extract to GLP-1, Fasting Plasma Insulin, Insulin concentrations measured during a standardized 2-h OGTT, and HOMA-IR.
Detailed description
Blood's participants will be examined fasting plasma insulin and glycated albumin (from fasting blood) and insulin measured during a standardized 2-h OGTT, DPP-4 enzyme, and GLP-1 (from standardized 2-h OGTT blood). Then, complete urinalysis test. Participants will be randomized to be two groups are group have been intervenced by capsules of A. paniculata or group placebo. Each group will be explained about procedure to consume capsules A. paniculata or placebo for 14 days, storage procedures, and the way to contact the investigators if adverse event happened. The investigators will contact participants to remember the schedule to consume capsules A. paniculata, ask whether the side effects or not, and ask the result of self monitoring blood glucose every three days by glucose meter have been given.
Before day 12th, participants will be contacted to come in visit 2nd. In visit 2nd (day 15th) will be done anamneses, assessment of compliance, reporting adverse event and side effect, physical examination, fasting plasma glucose test, fasting insulin, HOMA-IR, GA and complete urinalysis. Then, will be done standardized 2-h OGTT. Two hours later, it will be done plasma glucose level, insulin, DPP-4 enzyme, and GLP-1. Participants will be explained that they will not receive capsules of A. paniculata for 7 days (day 15th till 21th). This is called wash out.
Participants will be explained about procedures to consume capsule of A. paniculata or placebo in day 22th till 35th. Before day 32th, participants will be contacted to come in visit 3rd (day 36th). In visit 3rd, will be done anamneses, assessment of compliance, reporting adverse event and side effect, physical examination, fasting plasma glucose test, fasting insulin, HOMA-IR, GA and complete urinalysis. Then, will be done standardized 2-h OGTT. Two hours later, it will be done plasma glucose level, insulin, DPP-4 enzyme, and GLP-1.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Double blind (participant, investigator)
- Number of arms
- 4
- Model description
- Clinical Trials with Randomization, Double Blind, Crossover
| Arm | Type | Receives |
|---|---|---|
| Normal subject experimental | Experimental | Other: Andrographis Paniculata ExtParticipants get Andrographis Paniculata Extract 550 mg, two capsules, twice a day, for 14 days. |
| Normal subject placebo | Placebo comparator | Other: Andrographis Paniculata ExtParticipants get placebo consist of Lactose 98%, Mg 2%, two capsules, twice a day, for 14 days. |
| Prediabetes subject experimental | Experimental | Other: Andrographis Paniculata ExtParticipants get Andrographis Paniculata Extract 550 mg, two capsules, twice a day, for 14 days. |
| Prediabetes subject placebo | Placebo comparator | Other: Andrographis Paniculata ExtParticipants get placebo consist of Lactose 98%, Mg 2%, two capsules, twice a day, for 14 days. |
Who may qualify
- Ages
- 18 to 60 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (4 listed)
- Age 18 year old until 60 year old
- Normal glucose tolerance subject or prediabetes
- The kidney function (creatinine) and liver function (SGPT) in range normal
- Subject has signed agreement (informed consent)
Key exclusion criteria (6 listed)
- Pregnant
- Feeding baby
- Subject has comorbide or chronic disease uncontrolled
- Subject has cancer
- Subject consume medication influenced blood glucose such as steroid an suplement
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 |
|---|---|---|
| Andrographis Paniculata ExtGive the Androgaphis paniculata in prediabetes and normal subject for 14 days. | Other | Normal subject experimental, Normal subject placebo, Prediabetes subject experimental, Prediabetes subject placebo |
Primary outcome
GLP-1
Time frame: A measure assesing change from baseline GLP-1 at 14 days.
Index analyzes incretin effect
7 secondary outcomes
Fasting Insulin
Time frame: A measure assesing change from baseline GLP-1 at 14 days.
2h-OGTT Insulin
Time frame: A measure assesing change from baseline GLP-1 at 14 days.
HOMA-IR
Time frame: A measure assesing change from baseline GLP-1 at 14 days.
Fasting plasma glucose level
Time frame: A measure assesing change from baseline GLP-1 at 14 days.
2h-OGTT plasma glucose level
Time frame: A measure assesing change from baseline GLP-1 at 14 days.
Dypeptidil Peptidase 4 (DPP-4) Enzyme
Time frame: A measure assesing change from baseline GLP-1 at 14 days.
Glycated Albumin
Time frame: A measure assesing change from baseline GLP-1 at 14 days.
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 14 Sep 2020.
- Background: PubMed 22357723Wedick NM, Pan A, Cassidy A, Rimm EB, Sampson L, Rosner B, Willett W, Hu FB, Sun Q, van Dam RM. Dietary flavonoid intakes and risk of type 2 diabetes in US men and women. Am J Clin Nutr. 2012 Apr;95(4):925-33. doi: 10.3945/ajcn.111.028894. Epub 2012 Feb 22.
- Derived from this study: PubMed 35075363Tarigan TJE, Purwaningsih EH, Yusra, Abdullah M, Nafrialdi, Prihartono J, Saraswati MR, Subekti I. Effects of Sambiloto (Andrographis paniculata) on GLP-1 and DPP-4 Concentrations between Normal and Prediabetic Subjects: A Crossover Study. Evid Based Complement Alternat Med. 2022 Jan 15;2022:1535703. doi: 10.1155/2022/1535703. eCollection 2022.
- Individual participant dataSharing planned: No
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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.
Tri Juli Edi Tarigan, MD principal investigator
Fakultas Kedokteran Universitas Indonesia
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Andrographis Paniculata Ext in people with Increased Insulin, 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 4 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 14 Sep 2020. 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?
GLP-1 (time frame: A measure assesing change from baseline GLP-1 at 14 days.). 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 NCT03455049, which also lists 2 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 Sep 2020.