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Effect of jeju water on blood glucose levels in diabetic patients: a randomized controlled trial.

Koh G, Lee DH, Lee SA, Kang EK, Hwang O, Han HJ, Kim SY, Yang EJ, Kim MK, Chin HJ - Evid Based Complement Alternat Med (2013)

Bottom Line: In total, 196 patients were randomized and analyzed in the intention-to-treat (ITT) population (66 consuming S1, 63 consuming S2, and 67 consuming SS); 146 patients were considered in the PP population.There were no significant differences in the primary outcomes of the groups consuming S1, S2, or SS.Although we failed to achieve the primary outcome, it is possible that the Jeju waters improve glycemic control compared with the Seoul tap water in diabetic patients.

View Article: PubMed Central - PubMed

Affiliation: Department of Internal Medicine, Jeju National University School of Medicine, 102 Jejudaehakno, Jeju City, Jeju 690-756, Republic of Korea.

ABSTRACT
Jeju water is the groundwater of Jeju Island, a volcanic island located in Republic of Korea. We investigated whether Jeju water improved glycemic control in patients with diabetes. This was a 12-week single-center, double-blind, randomized, and controlled trial. The subjects daily drank a liter of one of three kinds of water: two Jeju waters (S1 and S2) and Seoul tap water (SS). The primary outcome was the proportion of patients in the per-protocol (PP) population achieving glycated hemoglobin (HbA1c) < 7.0% at week 12. In total, 196 patients were randomized and analyzed in the intention-to-treat (ITT) population (66 consuming S1, 63 consuming S2, and 67 consuming SS); 146 patients were considered in the PP population. There were no significant differences in the primary outcomes of the groups consuming S1, S2, or SS. However, the percentage of patients achieving HbA1c < 8% was significantly higher in the S2 group than in the SS group. In the ITT population, the 12-week HbA1c and fructosamine levels were lower in the S1 group than in the SS group and the 4-, 8-, and 12-week fructosamine levels were lower in the S2 group than in the SS group. Although we failed to achieve the primary outcome, it is possible that the Jeju waters improve glycemic control compared with the Seoul tap water in diabetic patients.

No MeSH data available.


Related in: MedlinePlus

Patient disposition.
© Copyright Policy - open-access
Related In: Results  -  Collection


getmorefigures.php?uid=PMC3852319&req=5

fig1: Patient disposition.

Mentions: After randomization, 172/196 patients completed the 12-week study: 60/67 in the SS group, 56/66 in the S1 group, and 56/63 in the S2 group. The reasons for discontinuation were consent withdrawal and adverse events. Seven patients in the SS group, 10 in the S1 group, and nine in the S2 group were excluded from the PP analysis because they violated the study protocol (change in antidiabetic medication or poor compliance with the protocol) or did not meet the inclusion/exclusion criteria. Consequently, 50 (25.5%) patients in the ITT population were not included in the PP population: 14 (20.9%) in the SS group, 20 (30.3%) in the S1 group, and 16 (25.4%) in the S2 group (not significantly different). The disposition of the patients is shown schematically in Figure 1.


Effect of jeju water on blood glucose levels in diabetic patients: a randomized controlled trial.

Koh G, Lee DH, Lee SA, Kang EK, Hwang O, Han HJ, Kim SY, Yang EJ, Kim MK, Chin HJ - Evid Based Complement Alternat Med (2013)

Patient disposition.
© Copyright Policy - open-access
Related In: Results  -  Collection

Show All Figures
getmorefigures.php?uid=PMC3852319&req=5

fig1: Patient disposition.
Mentions: After randomization, 172/196 patients completed the 12-week study: 60/67 in the SS group, 56/66 in the S1 group, and 56/63 in the S2 group. The reasons for discontinuation were consent withdrawal and adverse events. Seven patients in the SS group, 10 in the S1 group, and nine in the S2 group were excluded from the PP analysis because they violated the study protocol (change in antidiabetic medication or poor compliance with the protocol) or did not meet the inclusion/exclusion criteria. Consequently, 50 (25.5%) patients in the ITT population were not included in the PP population: 14 (20.9%) in the SS group, 20 (30.3%) in the S1 group, and 16 (25.4%) in the S2 group (not significantly different). The disposition of the patients is shown schematically in Figure 1.

Bottom Line: In total, 196 patients were randomized and analyzed in the intention-to-treat (ITT) population (66 consuming S1, 63 consuming S2, and 67 consuming SS); 146 patients were considered in the PP population.There were no significant differences in the primary outcomes of the groups consuming S1, S2, or SS.Although we failed to achieve the primary outcome, it is possible that the Jeju waters improve glycemic control compared with the Seoul tap water in diabetic patients.

View Article: PubMed Central - PubMed

Affiliation: Department of Internal Medicine, Jeju National University School of Medicine, 102 Jejudaehakno, Jeju City, Jeju 690-756, Republic of Korea.

ABSTRACT
Jeju water is the groundwater of Jeju Island, a volcanic island located in Republic of Korea. We investigated whether Jeju water improved glycemic control in patients with diabetes. This was a 12-week single-center, double-blind, randomized, and controlled trial. The subjects daily drank a liter of one of three kinds of water: two Jeju waters (S1 and S2) and Seoul tap water (SS). The primary outcome was the proportion of patients in the per-protocol (PP) population achieving glycated hemoglobin (HbA1c) < 7.0% at week 12. In total, 196 patients were randomized and analyzed in the intention-to-treat (ITT) population (66 consuming S1, 63 consuming S2, and 67 consuming SS); 146 patients were considered in the PP population. There were no significant differences in the primary outcomes of the groups consuming S1, S2, or SS. However, the percentage of patients achieving HbA1c < 8% was significantly higher in the S2 group than in the SS group. In the ITT population, the 12-week HbA1c and fructosamine levels were lower in the S1 group than in the SS group and the 4-, 8-, and 12-week fructosamine levels were lower in the S2 group than in the SS group. Although we failed to achieve the primary outcome, it is possible that the Jeju waters improve glycemic control compared with the Seoul tap water in diabetic patients.

No MeSH data available.


Related in: MedlinePlus