Diabetes Mellitus, Pre Diabetes
Conditions
Keywords
Impaired Fasting Glucose, Impaired Glucose Tolerance, 2hr -75gm Oral Glucose Tolerance Test, Diabetes Mellitus Prevention
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.
Interventions
DIETARY_SUPPLEMENTPolyherbal formulation
Test candidate will be administered per oral before / with meal in two divided doses
Sponsors
Hashmi Herbal Pharma (HHP) Registered Bahawalpur
Islamia University of Bahawalpur
Study design
Observational model
CASE_CROSSOVER
Time perspective
CROSS_SECTIONAL
Eligibility
Sex/Gender
ALL
Age
18 Years to 59 Years
Healthy volunteers
Yes
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Fasting Glucose Tolerance (FGT) | six weeks | enhancement of fasting glucose tolerance (\<100mg/dl) |
| HB-A1c | six week | improvement in glycated hemoglobin (HB-A1c) percentage \<6%, |
| Glucose Tolerance (GT) | six weeks | enhancement of oral glucose tolerance (\<140mg/dl) |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Lipid Profile | six weeks | serum Cholesterol level (mg/dl) |
Other
| Measure | Time frame | Description |
|---|---|---|
| Liver Functions | six week | Serum Glutamate pyruvate transaminase (SGPT) (mg/dl) |
| Kidney Function | six week | Serum creatinine (mg/dl) |
| Liver Function | six week | serum glutamate oxaloacetate transaminase (SGOT)(mg/dl) |
Countries
Pakistan
Outcome results
None listed