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The Effect of Andrographis Paniculata to GLP-1, Fasting Insulin, Insulin 2-h Post OGTT, and HOMA-IR

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ClinicalTrials.gov Identifier: NCT03455049
Recruitment Status : Recruiting
First Posted : March 6, 2018
Last Update Posted : April 4, 2018
Sponsor:
Information provided by (Responsible Party):
Dr Tri Juli Edi Tarigan, SpPD-KEMD, Indonesia University

Brief 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. 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.


Condition or disease Intervention/treatment Phase
Increased Insulin Other: Andrographis Paniculata Ext Not Applicable

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 Type : Interventional  (Clinical Trial)
Estimated Enrollment : 80 participants
Allocation: Randomized
Intervention Model: Crossover Assignment
Intervention Model Description: Clinical Trials with Randomization, Double Blind, Crossover
Masking: Double (Participant, Investigator)
Masking Description: Double Blind
Primary Purpose: Treatment
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
Actual Study Start Date : October 17, 2017
Estimated Primary Completion Date : May 30, 2018
Estimated Study Completion Date : May 30, 2018

Arm Intervention/treatment
Experimental: Normal subject experimental
Participants get Andrographis Paniculata Extract 550 mg, two capsules, twice a day, for 14 days.
Other: Andrographis Paniculata Ext
Give the Androgaphis paniculata in prediabetes and normal subject for 14 days.

Placebo Comparator: Normal subject placebo
Participants get placebo consist of Lactose 98%, Mg 2%, two capsules, twice a day, for 14 days.
Other: Andrographis Paniculata Ext
Give the Androgaphis paniculata in prediabetes and normal subject for 14 days.

Experimental: Prediabetes subject experimental
Participants get Andrographis Paniculata Extract 550 mg, two capsules, twice a day, for 14 days.
Other: Andrographis Paniculata Ext
Give the Androgaphis paniculata in prediabetes and normal subject for 14 days.

Placebo Comparator: Prediabetes subject placebo
Participants get placebo consist of Lactose 98%, Mg 2%, two capsules, twice a day, for 14 days.
Other: Andrographis Paniculata Ext
Give the Androgaphis paniculata in prediabetes and normal subject for 14 days.




Primary Outcome Measures :
  1. GLP-1 [ Time Frame: A measure assesing change from baseline GLP-1 at 14 days. ]
    Index analyzes incretin effect


Secondary Outcome Measures :
  1. Fasting Insulin [ Time Frame: A measure assesing change from baseline GLP-1 at 14 days. ]
    Index analyzes beta-cell secretion

  2. 2h-OGTT Insulin [ Time Frame: A measure assesing change from baseline GLP-1 at 14 days. ]
    Index analyzes beta-cell secretion after 2h-OGTT

  3. HOMA-IR [ Time Frame: A measure assesing change from baseline GLP-1 at 14 days. ]
    Index of insulin resistance

  4. Fasting plasma glucose level [ Time Frame: A measure assesing change from baseline GLP-1 at 14 days. ]
    Index analyzes beta-cell function

  5. 2h-OGTT plasma glucose level [ Time Frame: A measure assesing change from baseline GLP-1 at 14 days. ]
    Index analyzes beta-cell function after 2h-OGTT

  6. Dypeptidil Peptidase 4 (DPP-4) Enzyme [ Time Frame: A measure assesing change from baseline GLP-1 at 14 days. ]
    Index analyzes degradation of GLP-1 in Ileum

  7. Glycated Albumin [ Time Frame: A measure assesing change from baseline GLP-1 at 14 days. ]
    Index analyzes plasma glucose during 2 weeks



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Ages Eligible for Study:   18 Years to 60 Years   (Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  1. Age 18 year old until 60 year old
  2. Normal glucose tolerance subject or prediabetes
  3. The kidney function (creatinine) and liver function (SGPT) in range normal
  4. Subject has signed agreement (informed consent)

Exclusion Criteria:

  1. Pregnant
  2. Feeding baby
  3. Subject has comorbide or chronic disease uncontrolled
  4. Subject has cancer
  5. Subject consume medication influenced blood glucose such as steroid an suplement
  6. Insulin dependent diabetes

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03455049


Contacts
Contact: Tri Juli Edi Tarigan, MD 62 813 1544 83293 tje_tar@yahoo.com
Contact: Nida Amalina, PH 62 856 9703 6895 amalinanida@gmail.com

Locations
Indonesia
Faculty of Medicine, Universitas Indonesia Recruiting
Jakarta Pusat, DKI Jakarta, Indonesia, 10430
Contact: Tri Juli Edi Tarigan, MD    +62 813 15 483 293    tje_tar@yahoo.com   
Contact: Nida Amalina, PH    +62 856 9703 6895    amalinanida@gmail.com   
Sponsors and Collaborators
Indonesia University
Investigators
Principal Investigator: Tri Juli Edi Tarigan, MD Faculty of Medicine , Universitas Indonesia

Publications:
Responsible Party: Dr Tri Juli Edi Tarigan, SpPD-KEMD, MD, Endocrinologist, Indonesia University
ClinicalTrials.gov Identifier: NCT03455049     History of Changes
Other Study ID Numbers: IndonesiaU-02
First Posted: March 6, 2018    Key Record Dates
Last Update Posted: April 4, 2018
Last Verified: April 2018
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Product Manufactured in and Exported from the U.S.: No

Additional relevant MeSH terms:
Hyperinsulinism
Glucose Metabolism Disorders
Metabolic Diseases
Insulin
Andrographolide
Hypoglycemic Agents
Physiological Effects of Drugs
Anti-Inflammatory Agents
Anti-Inflammatory Agents, Non-Steroidal
Analgesics, Non-Narcotic
Analgesics
Sensory System Agents
Peripheral Nervous System Agents
Antirheumatic Agents
Antiprotozoal Agents
Antiparasitic Agents
Anti-Infective Agents
Antiviral Agents
Platelet Aggregation Inhibitors