PreDiabetes
Conditions
Brief summary
This study was conducted to investigate the effects of daily supplementation of deep sea water on improvement of hyperglycemia
Detailed description
This study was a 8 weeks, randomized, double-blind, placebo-controlled, cross-over clinical trial.
Interventions
OTHERPlacebo
Placeob water 440 ml/day for 8 weeks
OTHERDeep sea water
Deep sea water 440 ml/day for 8 weeks
Sponsors
Kyungpook National University Hospital
Chonbuk National University Hospital
Study design
Allocation
RANDOMIZED
Intervention model
CROSSOVER
Primary purpose
PREVENTION
Masking
DOUBLE (Subject, Investigator)
Eligibility
Sex/Gender
ALL
Age
19 Years to 70 Years
Healthy volunteers
Yes
Inclusion criteria
* Fasting plasma glucose concentration of 100-140 mg/dL or 2h-postprandial plasma glucose concentration of 140 \ 199 mg/dL
Exclusion criteria
* Patients with type 1 or type 2 diabetes * HbA1c ≥9.0% * Weight decreased by more than 10% within past 3 months * Have clinically significant acute or chronic cardiovascular system, endocrine system, immune system, respiratory system, hepatic biliary system, kidney and Urinary system, neuropsychiatry, musculoskeletal, inflammatory and hematologic malignancies, gastrointestinal disorders, etc. * Hypoglycemic agent, obesity medicine, lipid lowering agent within past 6 months or functional food within past 2 month * Subjects who have taken corticosteroid within past 1 months * History of alcohol or substance abuse * Participation in any other clinical trials within past 2 months * Laboratory test by show the following results * Serum AST (aspartate aminotransferase) or ALT (alanine aminotransferase) \> 2 times the upper limit of normal range * Serum Creatinine \> 2.0 mg/dl * Pregnancy or breast feeding * If a woman of childbearing doesn't accept the implementation of appropriate contraception * Principal Investigator judged inappropriate for participation in study because of Laboratory test result, etc
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Changes of blood glucose | Baseline, 8 weeks | Concentration of fasting and postprandial glucose during OGTT (oral glucose tolerance test) were assessed before and after the intervention |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| C-pepetide | Baseline, 8 weeks | Concentration of C-peptide were assessed before and after the intervention |
| HbA1c | Baseline, 8 weeks | Concentration of HbA1c were assessed before and after the intervention |
| Homeostatic model assessment - insulin resistance (HOMA-IR) | Baseline, 8 weeks | Concentration of HOMA-IR were assessed before and after the intervention |
| Total cholesterol | Baseline, 8 weeks | Concentration of total cholesterol were assessed before and after the intervention |
| Triglyceride | Baseline, 8 weeks | Concentration of triglyceride were assessed before and after the intervention |
| HDL-cholesterol | Baseline, 8 weeks | Concentration of HDL-cholesterol were assessed befor and after the intervention |
| Changes of blood insulin | Baseline, 8 weeks | Concentration of blood insulin were assessed before and after the intervention |
| Weight | Baseline, 8 weeks | Concentration of weight were assessed befor and after the intervention |
| BMI | Baseline, 8 weeks | Concentration of BMI were assessed before and after the invervention |
| Body fat mass | Baseline, 8 weeks | Concentration of body fat mass were assessed before and after the intervention |
| Percent of body fat mass | Baseline, 8 weeks | Concentration of percent of body fass mass were assessed before and after the intervention |
| Waist circumference | Baseline, 8 weeks | Concentration of waist circumference were assessed before and after the intervention |
| Waist-hip ratio (WHR) | Baseline, 8 weeks | Concentration of WHR were assessed before and after the intervention |
| LDL-cholesterol | Baseline, 8 weeks | Concentration of LDL-cholesterol were assessed befor and after the intervention |
Outcome results
None listed