Trial Outcomes & Findings for Preventing Metabolic Side Effects of Thiazide Diuretics With KMgCitrate (NCT NCT02665117)
NCT ID: NCT02665117
Last Updated: 2023-10-25
Results Overview
Fasting plasma glucose was measured from venous blood sample at week 4 and week 16
Recruitment status
COMPLETED
Study phase
NA
Target enrollment
61 participants
Primary outcome timeframe
week 4 and week 16
Results posted on
2023-10-25
Participant Flow
Participant milestones
| Measure |
KMgCit + Chlorthalidone
After a run-in period of 2-3 weeks on Chlorthalidone, patients will be randomized to the addition of KMgCit for 4 months.
Potassium Magnesium Citrate (KMgCit): KMgCit will be administer for 4 months with chlorthalidone.
Chlorthalidone: Chlorthalidone will be administered for 2-3 weeks. Then either KCL or KMgCit will be added to Chlorthalidone and the combination will be taken for 4 months.
|
KCl + Chlorthalidone
After a run-in period of 2-3 weeks on Chlorthalidone, patients will be randomized to the addition of KCl for 4 months.
Potassium Chloride (KCl): KCl will be administer for 4 months with chlorthalidone.
Chlorthalidone: Chlorthalidone will be administered for 2-3 weeks. Then either KCL or KMgCit will be added to Chlorthalidone and the combination will be taken for 4 months.
|
|---|---|---|
|
Overall Study
STARTED
|
30
|
31
|
|
Overall Study
COMPLETED
|
29
|
31
|
|
Overall Study
NOT COMPLETED
|
1
|
0
|
Reasons for withdrawal
| Measure |
KMgCit + Chlorthalidone
After a run-in period of 2-3 weeks on Chlorthalidone, patients will be randomized to the addition of KMgCit for 4 months.
Potassium Magnesium Citrate (KMgCit): KMgCit will be administer for 4 months with chlorthalidone.
Chlorthalidone: Chlorthalidone will be administered for 2-3 weeks. Then either KCL or KMgCit will be added to Chlorthalidone and the combination will be taken for 4 months.
|
KCl + Chlorthalidone
After a run-in period of 2-3 weeks on Chlorthalidone, patients will be randomized to the addition of KCl for 4 months.
Potassium Chloride (KCl): KCl will be administer for 4 months with chlorthalidone.
Chlorthalidone: Chlorthalidone will be administered for 2-3 weeks. Then either KCL or KMgCit will be added to Chlorthalidone and the combination will be taken for 4 months.
|
|---|---|---|
|
Overall Study
Physician Decision
|
1
|
0
|
Baseline Characteristics
Preventing Metabolic Side Effects of Thiazide Diuretics With KMgCitrate
Baseline characteristics by cohort
| Measure |
KMgCit + Chlorthalidone
n=29 Participants
After a run-in period of 2-3 weeks on Chlorthalidone, patients will be randomized to the addition of KMgCit for 4 months.
Potassium Magnesium Citrate (KMgCit): KMgCit will be administer for 4 months with chlorthalidone.
Chlorthalidone: Chlorthalidone will be administered for 2-3 weeks. Then either KCL or KMgCit will be added to Chlorthalidone and the combination will be taken for 4 months.
|
KCl + Chlorthalidone
n=31 Participants
After a run-in period of 2-3 weeks on Chlorthalidone, patients will be randomized to the addition of KCl for 4 months.
Potassium Chloride (KCl): KCl will be administer for 4 months with chlorthalidone.
Chlorthalidone: Chlorthalidone will be administered for 2-3 weeks. Then either KCL or KMgCit will be added to Chlorthalidone and the combination will be taken for 4 months.
|
Total
n=60 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Continuous
|
60.7 years
STANDARD_DEVIATION 9.3 • n=5 Participants
|
58.1 years
STANDARD_DEVIATION 12.8 • n=7 Participants
|
59.4 years
STANDARD_DEVIATION 11.2 • n=5 Participants
|
|
Sex: Female, Male
Female
|
14 Participants
n=5 Participants
|
11 Participants
n=7 Participants
|
25 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
15 Participants
n=5 Participants
|
20 Participants
n=7 Participants
|
35 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Hispanic or Latino
|
3 Participants
n=5 Participants
|
2 Participants
n=7 Participants
|
5 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Not Hispanic or Latino
|
26 Participants
n=5 Participants
|
29 Participants
n=7 Participants
|
55 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Region of Enrollment
United States
|
29 participants
n=5 Participants
|
31 participants
n=7 Participants
|
60 participants
n=5 Participants
|
PRIMARY outcome
Timeframe: week 4 and week 16Fasting plasma glucose was measured from venous blood sample at week 4 and week 16
Outcome measures
| Measure |
KMgCit + Chlorthalidone
n=29 Participants
After a run-in period of 2-3 weeks on Chlorthalidone, patients will be randomized to the addition of KMgCit for 4 months.
Potassium Magnesium Citrate (KMgCit): KMgCit will be administer for 4 months with chlorthalidone.
Chlorthalidone: Chlorthalidone will be administered for 2-3 weeks. Then either KCL or KMgCit will be added to Chlorthalidone and the combination will be taken for 4 months.
|
KCl + Chlorthalidone
n=31 Participants
After a run-in period of 2-3 weeks on Chlorthalidone, patients will be randomized to the addition of KCl for 4 months.
Potassium Chloride (KCl): KCl will be administer for 4 months with chlorthalidone.
Chlorthalidone: Chlorthalidone will be administered for 2-3 weeks. Then either KCL or KMgCit will be added to Chlorthalidone and the combination will be taken for 4 months.
|
|---|---|---|
|
Change in Fasting Plasma Glucose From Week 4 to Week 16
|
-5.6 mg/dL
Standard Deviation 13.3
|
2.3 mg/dL
Standard Deviation 9.9
|
SECONDARY outcome
Timeframe: baseline to week 16Will be measured using hepatic magnetic resonance imaging at baseline and at week 16
Outcome measures
| Measure |
KMgCit + Chlorthalidone
n=19 Participants
After a run-in period of 2-3 weeks on Chlorthalidone, patients will be randomized to the addition of KMgCit for 4 months.
Potassium Magnesium Citrate (KMgCit): KMgCit will be administer for 4 months with chlorthalidone.
Chlorthalidone: Chlorthalidone will be administered for 2-3 weeks. Then either KCL or KMgCit will be added to Chlorthalidone and the combination will be taken for 4 months.
|
KCl + Chlorthalidone
n=19 Participants
After a run-in period of 2-3 weeks on Chlorthalidone, patients will be randomized to the addition of KCl for 4 months.
Potassium Chloride (KCl): KCl will be administer for 4 months with chlorthalidone.
Chlorthalidone: Chlorthalidone will be administered for 2-3 weeks. Then either KCL or KMgCit will be added to Chlorthalidone and the combination will be taken for 4 months.
|
|---|---|---|
|
Chang in Hepatic Fat Measured at Baseline and Week 16
|
0.31 percent
Standard Deviation 2.74
|
1.59 percent
Standard Deviation 4.9
|
SECONDARY outcome
Timeframe: baseline to week 16Will be measured using magnetic resonance imaging at baseline and at week 16
Outcome measures
| Measure |
KMgCit + Chlorthalidone
n=19 Participants
After a run-in period of 2-3 weeks on Chlorthalidone, patients will be randomized to the addition of KMgCit for 4 months.
Potassium Magnesium Citrate (KMgCit): KMgCit will be administer for 4 months with chlorthalidone.
Chlorthalidone: Chlorthalidone will be administered for 2-3 weeks. Then either KCL or KMgCit will be added to Chlorthalidone and the combination will be taken for 4 months.
|
KCl + Chlorthalidone
n=19 Participants
After a run-in period of 2-3 weeks on Chlorthalidone, patients will be randomized to the addition of KCl for 4 months.
Potassium Chloride (KCl): KCl will be administer for 4 months with chlorthalidone.
Chlorthalidone: Chlorthalidone will be administered for 2-3 weeks. Then either KCL or KMgCit will be added to Chlorthalidone and the combination will be taken for 4 months.
|
|---|---|---|
|
Change in Muscle Magnesium Content Measured at Baseline and Week 16
|
-0.01 mM
Standard Deviation 0.1
|
0.02 mM
Standard Deviation 0.08
|
SECONDARY outcome
Timeframe: week 4 to week 16Will be measured from venous blood sample from week 4 to week 16
Outcome measures
| Measure |
KMgCit + Chlorthalidone
n=29 Participants
After a run-in period of 2-3 weeks on Chlorthalidone, patients will be randomized to the addition of KMgCit for 4 months.
Potassium Magnesium Citrate (KMgCit): KMgCit will be administer for 4 months with chlorthalidone.
Chlorthalidone: Chlorthalidone will be administered for 2-3 weeks. Then either KCL or KMgCit will be added to Chlorthalidone and the combination will be taken for 4 months.
|
KCl + Chlorthalidone
n=31 Participants
After a run-in period of 2-3 weeks on Chlorthalidone, patients will be randomized to the addition of KCl for 4 months.
Potassium Chloride (KCl): KCl will be administer for 4 months with chlorthalidone.
Chlorthalidone: Chlorthalidone will be administered for 2-3 weeks. Then either KCL or KMgCit will be added to Chlorthalidone and the combination will be taken for 4 months.
|
|---|---|---|
|
Change in FGF23 From Week 4 to Week 16
|
38.1 pg/ml
Standard Deviation 123.3
|
13.6 pg/ml
Standard Deviation 104.1
|
Adverse Events
KMgCit + Chlorthalidone
Serious events: 0 serious events
Other events: 2 other events
Deaths: 0 deaths
KCl + Chlorthalidone
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
Serious adverse events
Adverse event data not reported
Other adverse events
| Measure |
KMgCit + Chlorthalidone
n=29 participants at risk
After a run-in period of 2-3 weeks on Chlorthalidone, patients will be randomized to the addition of KMgCit for 4 months.
Potassium Magnesium Citrate (KMgCit): KMgCit will be administer for 4 months with chlorthalidone.
Chlorthalidone: Chlorthalidone will be administered for 2-3 weeks. Then either KCL or KMgCit will be added to Chlorthalidone and the combination will be taken for 4 months.
|
KCl + Chlorthalidone
n=31 participants at risk
After a run-in period of 2-3 weeks on Chlorthalidone, patients will be randomized to the addition of KCl for 4 months.
Potassium Chloride (KCl): KCl will be administer for 4 months with chlorthalidone.
Chlorthalidone: Chlorthalidone will be administered for 2-3 weeks. Then either KCL or KMgCit will be added to Chlorthalidone and the combination will be taken for 4 months.
|
|---|---|---|
|
Musculoskeletal and connective tissue disorders
Mechanical Fracture
|
3.4%
1/29 • Number of events 1 • 4 months
|
0.00%
0/31 • 4 months
|
|
General disorders
Syncopal Episode
|
3.4%
1/29 • Number of events 1 • 4 months
|
0.00%
0/31 • 4 months
|
Additional Information
Dr. Wanpen Vongpatanasin
UT Southwestern Medical Center
Phone: 214-648-9078
Email: [email protected]
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place