Evaluation of Coffee Therapy for Improvement of Renal Oxygenation

Coffee, Renal Oxygenation, Blood Flow and Glomerular Filtration Rate in Early Diabetic Kidney Disease.

Sponsors

Lead Sponsor: University of Colorado Denver School of Medicine Barbara Davis Center

Collaborator: Johns Hopkins University

Source University of Colorado Denver School of Medicine Barbara Davis Center
Brief Summary

Over 1.25 million Americans have Type 1 Diabetes (T1D), increasing risk for early death from cardiovascular disease (CVD). Despite advances in glycemic and blood pressure control, a child diagnosed with T1D is expected to live up to 17 years less than non-diabetic peers. The strongest risk factor for CVD and mortality in T1D is diabetic kidney disease (DKD). Current treatments, such as control of hyperglycemia and hypertension, are beneficial, but only partially protect against DKD. This limited progress may relate to a narrow focus on clinical manifestations of disease, rather than on the initial metabolic derangements underlying the initiation of DKD. Renal hypoxia, stemming from a potential metabolic mismatch between increased renal energy expenditure and impaired substrate utilization, is increasingly proposed as a unifying early pathway in the development of DKD. T1D is impacted by several mechanisms which increase renal ATP consumption and decrease ATP generation.

Caffeine, a methylxanthine, is known to alter kidney function by several mechanisms including natriuresis, hemodynamics and renin-angiotensin-aldosterone system. In contrast, to other natriuretic agents, caffeine is thought to fully inhibit the local tubuloglomerular feedback (TGF) response to increased distal sodium delivery. This observation has broad-ranging implications as caffeine can reduce renal oxygen (O2) consumption without impairing effective renal plasma flow (ERPF) and glomerular filtration rate (GFR).

There are also data suggesting that chemicals in coffee besides caffeine may provide important cardio-renal protection. Yet, there are no data examining the impact of coffee-induced natriuresis on intrarenal hemodynamic function and renal energetics in youth-onset T1D. Our overarching hypothesis in the proposed pilot and feasibility trial is that coffee drinking improves renal oxygenation by reducing renal O2 consumption without impairing GFR and ERPF. To address these hypotheses, we will measure GFR, ERPF, renal perfusion and oxygenation in response to 7 days of cold brew coffee (one Starbucks® Cold brew 325ml bottle daily [205mg caffeine]) in an open-label pilot and feasibility trial in 10 adolescents with T1D already enrolled in the CASPER Study (PI: Bjornstad).

Overall Status Active, not recruiting
Start Date July 1, 2019
Completion Date April 30, 2021
Primary Completion Date January 21, 2020
Phase Phase 2
Study Type Interventional
Primary Outcome
Measure Time Frame
Renal Oxygenation 1 hour
Renal Perfusion 1 hour
Secondary Outcome
Measure Time Frame
Glomerular Filtration Rate 4 hours
Effective Renal Plasma Flow 4 hours
Tubular Injury Markers 4 hours
Enrollment 10
Condition
Intervention

Intervention Type: Drug

Intervention Name: Starbucks® Cold brew - 325ml bottle

Description: Starbucks® Cold brew 325ml bottles daily [205mg caffeine] will be provided to the participants. Participants will be instructed to drink 1 bottle every morning between 6 and 9 am for 6 days prior to the post-intervention visit. The 7th day is the post-intervention visit, and participants will be asked to drink 1 bottle the morning of the study visit

Arm Group Label: Cold Brew Coffee

Eligibility

Criteria:

Inclusion Criteria:

- Youth with T1D (antibody +) with <10 year duration

- Age 12-21 years

- Weight >57 lbs and <350 lbs

- BMI >5th %ile

- HbA1c <12%

- Previous exposure to caffeine

Exclusion Criteria:

- Anemia

- Allergy to shellfish or iodine

- Severe illness, recent DKA

- Tachyarrhythmias, ADHD, tremors, tics, Tourette's, arrythmias, insomnia, overactive bladder

- eGFR <60 ml/min/1.73 m2 or creatinine > 1.5 mg/dl or history of ACR >300 mg/g

- MRI Scanning contraindications (claustrophobia, implantable metal devices that are non-MRI compatible, >350 lbs)

- Pregnancy or nursing

- ACE inhibitors, angiotensin receptor blockers (ARBs), diuretics, sodium-glucose co-transport (SGLT) 2 or 1 blockers, daily NSAIDs or aspirin, sulfonamides, thiazolsulfone or probenecid, atypical antipsychotics, steroids

Gender: All

Minimum Age: 12 Years

Maximum Age: 21 Years

Healthy Volunteers: No

Location
Facility: Children's Hospital Colorado
Location Countries

United States

Verification Date

April 2020

Responsible Party

Type: Principal Investigator

Investigator Affiliation: University of Colorado Denver School of Medicine Barbara Davis Center

Investigator Full Name: Petter Bjornstad

Investigator Title: Assistant Professor - Department of Pediatrics & Medicine

Has Expanded Access No
Condition Browse
Number Of Arms 1
Arm Group

Label: Cold Brew Coffee

Type: Experimental

Description: 6 days of drinking 1 bottle of Starbucks® Cold brew 325ml [205 mg caffeine] every morning between 6am-9am.

Acronym COFFEE
Patient Data Undecided
Study Design Info

Allocation: N/A

Intervention Model: Single Group Assignment

Primary Purpose: Treatment

Masking: None (Open Label)

Source: ClinicalTrials.gov