Clinical trial NCT03884920: Glucose Tolerance and Prevention of Diabetes Mellitus Type 2 by Polyherbal Formulation
Official title: Impaired Glucose Tolerance and Prevention of Diabetes Mellitus Type 2 by Polyherbal Formulation of Eastern Medicine
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Diabetes Mellitus
Pre Diabetes
Keywords: Impaired Fasting Glucose
Impaired Glucose Tolerance
2hr -75gm Oral Glucose Tolerance Test
Diabetes Mellitus Prevention
Lead sponsor: Islamia University of Bahawalpur
Sponsor class: OTHER
Collaborators: name: Hashmi Herbal Pharma (HHP) Registered Bahawalpur
First posted: 2019-03-21
Enrollment: 57
Sex: ALL
Minimum age (years): 18
Maximum age (years): 59
Standard ages: ADULT
Accepts healthy volunteers: yes
Observational model: CASE_CROSSOVER
Time perspective: CROSS_SECTIONAL
Sampling method: PROBABILITY_SAMPLE
Study population: * community samples will be obtained from the area of Bahawalpur
* Model Town A, B, and
* remote areas of district Bahawalpur consisting of Khairpur Tamewali city population

Brief summary: Primary protocol to this study is to develop a natural remedy to prevent diabetes mellitus in pre-diabetic state and elaborate the effectiveness of polyherbal formulation for carrying out Phase-II, III and IV. It also aimed at to see the level of difference of glucose tolerance and impaired fasting glucose and impaired glucose tolerance between pre-diabetic and diabetic to evaluate the potential benefit for treatment of insulin resistance and sensitivity. To see the for prevention of Diabetes Mellitus (DM) and stopping / delaying the onset of DM.

Detailed description: This study is a clinical trial study to evaluate the potential of prevention in pre-diabetics and to prevent onset of diabetes mellitus. For this purpose, volunteers will be enrolled in the study by observing the Helsinki Declaration for clinical trials.

volunteers will be screened for the impaired glucose tolerance or impaired fasting glucose or at risk to develop diabetes mellitus type 2.

On screening, pre-diabetics and early onset diabetics with no previous history of treatment etc will be grouped into A and B.

Biochemical evaluations will be carried out at base line and followed by three weeks intervention and evaluation of biomarkers and at sixth week for further evaluation.

Collected data will be evaluated for primary out comes and secondary out come. statistical analysis will be done. One year followup of participants was conducted.

Eligibility criteria: Inclusion Criteria:

* Age: 18-59
* Impaired Fasting Glucose (100-125mg/dl)
* Impaired Glucose Tolerance (140-199mg/dl) 2h-75gm OGTT
* History of Diabetes in first degree relation with one condition
* At high risk with BMI \> 35%
* Early onset diabetic / accidental on screening (glucose \>200mg/dl)

Exclusion Criteria:

* on renal dialysis;
* an acute or terminal illness or serious mental illness;
* history of recent coronary event within the last 12 months;
* a recent history of acute medical problem or admission to hospital;
* any other severe medical conditions that need intervention / treatment
* has poor short-term prognosis (expected death in \<2 years);
* is planning to travel for longer than 6 weeks during the 6-week intervention period; or
* is with compromised liver / kidney / cardiac function
* older patients of DM taking any form of medication / intervention

Primary outcomes:
measure: Fasting Glucose Tolerance (FGT)
timeFrame: six weeks
measure: Glucose Tolerance (GT)
timeFrame: six weeks
measure: HB-A1c
timeFrame: six week
Secondary outcomes:
measure: Lipid Profile
timeFrame: six weeks
measure: Lipid Profile
timeFrame: Six Weeks
measure: Lipid Profile
timeFrame: Six week
measure: Lipid Profile
timeFrame: six week
Other outcomes:
measure: Liver Functions
timeFrame: six week
measure: Liver Function
timeFrame: six week
measure: Liver Function
timeFrame: six week
measure: Kidney Function
timeFrame: six week
measure: Kidney Function
timeFrame: six week
Locations:
city: Khairpur Tamewali
country: Pakistan
facility: Hashmi Dawakhana
state: Punjab
city: Bahawalpur
country: Pakistan
facility: University College of Conventional Medicine
Study officials:
affiliation: scholar
name: H A Sattar Hashmi, M.Phil
role: PRINCIPAL_INVESTIGATOR
affiliation: AP
name: Dr K A.Ansari, Ph.D
role: STUDY_DIRECTOR
References: