Safety and Efficacy of Chlorthalidone in Type 1 Diabetes

• Sponsor: University of Rochester (Other)
• Overall Status: Terminated
• CT.gov ID: NCT03325114
• Collaborator: National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK) (NIH)
• Enrollment: 1
• Location: 1
• Arm: 1
• Actual Duration (Months): 11.1
• Patients Per Site Per Month: 0.1

Study Details

Study Description

Brief Summary

This open-label study will determine if chlorthalidone is safe and effective for the use of reducing urinary calcium excretion over 4 weeks in subjects with type 1 diabetes

Condition or Disease	Intervention/Treatment	Phase
Type 1 Diabetes Mellitus; Hypercalciuria	Drug: Chlorthalidone	Phase 2

Detailed Description

Type 1 diabetes (T1D) is associated with increased urinary calcium loss, which may contribute to the low bone mineral density and increased fracture risk observed in patients with this condition. Chlorthalidone is a thiazide-like diuretic that is commonly used to reduce urinary calcium excretion in other conditions such as idiopathic hypercalciuria. Its safety and efficacy has not been specifically tested in an adolescent type 1 diabetes population.

T1D subjects with hypercalciuria and who meet inclusion/exclusion criteria will be given chlorthalidone daily. Blood and urine tests, blood pressure, and glycemic control will be assessed at weekly study visits for 4 weeks.

Study Design

• Study Type: Interventional
• Actual Enrollment: 1 participants
• Allocation: N/A
• Intervention Model: Single Group Assignment
• Masking: None (Open Label)
• Primary Purpose: Treatment
• Official Title: Safety and Efficacy of Chlorthalidone to Reduce Urinary Calcium Excretion in Adolescents/Yount Adult With Type 1 Diabetes
• Actual Study Start Date: Jun 28, 2019
• Actual Primary Completion Date: Jun 1, 2020
• Actual Study Completion Date: Jun 1, 2020

Arms and Interventions

Arm	Intervention/Treatment
Other: Chlorthalidone Chlorthalidone 12.5-50 mg by mouth daily for 4 weeks	Drug: Chlorthalidone; Chlorthalidone 12.5-5 mg by mouth daily for 4 weeks

Outcome Measures

Primary Outcome Measures

1. Urinary Calcium Excretion [Assessed at baseline and at 4 weeks]

   Change in 24 hour urine calcium excretion

2. Hypokalemia [Assessed weekly for up to 4 weeks or until hypokalemia develops]

   Serum potassium decreased to <3.5 milliequivalent/L

3. Hypercalcemia [Assessed weekly for up to 4 weeks or until hypercalcemia develops]

   Serum calcium increased to >10.5 mg/dL

4. Hyperglycemia [Assessed at baseline and at 4 weeks]

   Change in serum fructosamine

Eligibility Criteria

Criteria

• Ages Eligible for Study: 12 Years to 21 Years
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: No

Inclusion Criteria:

• Diagnosis of T1D

• Age 12-21 years

• Tanner Stage 2 or greater pubertal development

• Urine calcium excretion ≥ 4 mg/kg/day

• Able to swallow pills

Exclusion Criteria:

• BMI > 99th percentile for age (<18 years) or BMI >35 kg/m2 (≥ 18 years)

• Coexistent conditions that may affect calcium metabolism including:

• celiac disease

• Graves' Disease

• Addison's disease

• hypo- or hyperparathyroidism

• History of diabetes related complications including:

• neuropathy

• retinopathy

• nephropathy

• gastroparesis

• History of oral or inhaled corticosteroid use for ≥ 5 consecutive days within the past month

• History of any diuretic use within the past month

• Laboratory abnormalities on screening bloodwork including:

• estimated glomerular filtration rate <90 mL/min per 1.73 m2 of body surface area

• serum calcium >10.5 mg/dL

• serum potassium <3.5 mmol/L

• Systolic or diastolic blood pressure <5th percentile for age and sex50 for age <18 years or systolic <90 mmHg or diastolic blood pressure <60 mmHG for age ≥18 years

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	University of Rochester	Rochester	New York	United States	14642

Sponsors and Collaborators

• University of Rochester
• National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)

Investigators

None specified.

Study Documents (Full-Text)

• Study Protocol and Statistical Analysis Plan - Oct 10, 2017

More Information

Publications

None provided.

• Responsible Party: University of Rochester
• ClinicalTrials.gov Identifier: NCT03325114
• Other Study ID Numbers: 66282; 1K23DK114477-01
• First Posted: Oct 30, 2017
• Last Update Posted: Jan 5, 2021
• Last Verified: Dec 1, 2020

• Individual Participant Data (IPD) Sharing Statement: No
• Plan to Share IPD: No
• Studies a U.S. FDA-regulated Drug Product: Yes
• Studies a U.S. FDA-regulated Device Product: No
• Product Manufactured in and Exported from the U.S.: Yes
• Keywords provided by University of Rochester: type 1 diabetes; hypercalciuria
• Additional relevant MeSH terms: Diabetes Mellitus; Diabetes Mellitus, Type 1; Hypercalciuria; Chlorthalidone

Study Results

Participant Flow

Arm/Group Title	Chlorthalidone
Arm/Group Description	Chlorthalidone 12.5-50 mg by mouth daily for 4 weeks Chlorthalidone: Chlorthalidone 12.5-5 mg by mouth daily for 4 weeks
Period Title: Overall Study
STARTED	1
COMPLETED	0
NOT COMPLETED	1

Baseline Characteristics

Arm/Group Title	Chlorthalidone
Arm/Group Description	Chlorthalidone 12.5-50 mg by mouth daily for 4 weeks Chlorthalidone: Chlorthalidone 12.5-5 mg by mouth daily for 4 weeks
Overall Participants	0
Age () []
<=18 years
Between 18 and 65 years
>=65 years
Age () []
Sex: Female, Male () []
Female
Male
Race (NIH/OMB) () []
American Indian or Alaska Native
Asian
Native Hawaiian or Other Pacific Islander
Black or African American
White
More than one race
Unknown or Not Reported
Region of Enrollment (participants) []

Outcome Measures

1. Primary Outcome

Title	Urinary Calcium Excretion
Description	Change in 24 hour urine calcium excretion
Time Frame	Assessed at baseline and at 4 weeks

Outcome Measure Data

Analysis Population Description

Due to only one participant being enrolled there are concerns regarding patient confidentiality, therefore no data is being reported.

Arm/Group Title	Chlorthalidone
Arm/Group Description	Chlorthalidone 12.5-50 mg by mouth daily for 4 weeks Chlorthalidone: Chlorthalidone 12.5-5 mg by mouth daily for 4 weeks
Measure Participants	0

2. Primary Outcome

Title	Hypokalemia
Description	Serum potassium decreased to <3.5 milliequivalent/L
Time Frame	Assessed weekly for up to 4 weeks or until hypokalemia develops

Outcome Measure Data

Analysis Population Description

Due to only one participant being enrolled there are concerns regarding patient confidentiality, therefore no data is being reported.

Arm/Group Title	Chlorthalidone
Arm/Group Description	Chlorthalidone 12.5-50 mg by mouth daily for 4 weeks Chlorthalidone: Chlorthalidone 12.5-5 mg by mouth daily for 4 weeks
Measure Participants	0

3. Primary Outcome

Title	Hypercalcemia
Description	Serum calcium increased to >10.5 mg/dL
Time Frame	Assessed weekly for up to 4 weeks or until hypercalcemia develops

Outcome Measure Data

Analysis Population Description

Due to only one participant being enrolled there are concerns regarding patient confidentiality, therefore no data is being reported.

Arm/Group Title	Chlorthalidone
Arm/Group Description	Chlorthalidone 12.5-50 mg by mouth daily for 4 weeks Chlorthalidone: Chlorthalidone 12.5-5 mg by mouth daily for 4 weeks
Measure Participants	0

4. Primary Outcome

Title	Hyperglycemia
Description	Change in serum fructosamine
Time Frame	Assessed at baseline and at 4 weeks

Outcome Measure Data

Analysis Population Description

Due to only one participant being enrolled there are concerns regarding patient confidentiality, therefore no data is being reported.

Arm/Group Title	Chlorthalidone
Arm/Group Description	Chlorthalidone 12.5-50 mg by mouth daily for 4 weeks Chlorthalidone: Chlorthalidone 12.5-5 mg by mouth daily for 4 weeks
Measure Participants	0

Adverse Events

Time Frame	4 weeks
Adverse Event Reporting Description	Due to only one participant being enrolled there are concerns regarding patient confidentiality, therefore no data is being reported.
Arm/Group Title	Chlorthalidone
Arm/Group Description	Chlorthalidone 12.5-50 mg by mouth daily for 4 weeks Chlorthalidone: Chlorthalidone 12.5-5 mg by mouth daily for 4 weeks
All Cause Mortality
	Chlorthalidone
	Affected / at Risk (%)	# Events
Total	0/0 (NaN)
Serious Adverse Events
	Chlorthalidone
	Affected / at Risk (%)	# Events
Total	0/0 (NaN)
Other (Not Including Serious) Adverse Events
	Chlorthalidone
	Affected / at Risk (%)	# Events
Total	0/0 (NaN)

Limitations/Caveats

[Not Specified]

More Information

Certain Agreements

All Principal Investigators ARE employed by the organization sponsoring the study.

There is NOT an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.