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Clinical trial information and results are updated daily from ClinicalTrials.gov. The latest data update was conducted on 06/14/2021.

SGLT-2 Inhibition, Metabolomics and Cardiovascular/Kidney Disease

Clinicaltrials.gov identifier NCT03919656

Recruitment Status Not yet recruiting

First Posted April 18, 2019

Last update posted April 23, 2019

Study Description

Brief summary:

This study evaluates the metabolomics changes associated with dapagliflozin treatment in patients with type 2 diabetes mellitus (T2DM). The participants in the study will be randomized to receive 10 mg dapagliflozin or placebo once daily for 12 weeks.

  • Condition or Disease:Type 2 Diabetes Mellitus
  • Intervention/Treatment: Drug: Dapagliflozin 10 mg
    Drug: Placebo Oral Tablet
  • Phase: Phase 4
Detailed Description

In this study, we hypothesize that metabolomics changes that occur in patients with T2DM after initiating SGLT2i (sodium-glucose cotransporter 2 inhibitors) treatment may be responsible for the beneficial cardiovascular and kidney effects observed in clinical trials with SGLT2i. Also, we propose that the study of the specific metabolome associated with the treatment with SGLT2i could help identify the possible metabolites and molecules that reduce CVD (cardiovascular disease) and renal disease in patients with T2DM. The participants in the study will be randomized to receive 10 mg dapagliflozin or placebo once daily of for 12 weeks. Besides, all participants will be advised to engage in 150 min or more of moderate-to vigorous intensity physical activity per week, spread over at least 3 days/week, with no more than 2 consecutive days without activity and to engage in 2-3 sessions/week of resistance exercise on nonconsecutive days. Moreover, these patients will be advised to follow a lifestyle program that achieve a 500-750 kcal/day energy deficit or provide≈1,200-1,500 kcal/day for women and 1,500-1,800 kcal/day for men, adjusted for the individual's baseline body weight.

Study Design
  • Study Type: Interventional
  • Estimated Enrollment: 60 participants
  • Allocation: Randomized
  • Intervention Model: Parallel Assignment
  • Intervention Model Description: Patients will be randomized in a 1:1 ratio
  • Masking: Double (Participant, Investigator)
  • Primary Purpose: Basic Science
  • Official Title: SGLT-2 Inhibition and Cardiovascular Disease. Metabolomics Study of Potential Factors Involved in Cardio- and Nephroprotection
  • Estimated Study Start Date: May 2019
  • Estimated Primary Completion Date: December 2019
  • Estimated Study Completion Date: April 2020
Arms and interventions
Arm Intervention/treatment
Experimental: Dapagliflozin
Dapagliflozin 10 mg daily (orally)
Drug: Dapagliflozin 10 mg
Dapagliflozin 10 mg daily in a green, plain, diamond shaped, film coated tablet (orally)
Placebo Comparator: Placebo
Matching placebo for dapagliflozin daily (orally). Does not contain active ingredient
Drug: Placebo Oral Tablet
Green, plain, diamond shaped, film coated tablet (orally). Does not contain active ingredient
Outcome Measures
  • Primary Outcome Measures: 1. Metabolomics changes in blood [ Time Frame: From baseline to week 12 ]
    Targeted and quantitative analysis by ultra-high-resolution liquid chromatography coupled to triple quadrupole mass spectrometry (UHPL-QqQ/MS). Analysis of specific families of metabolites selected from hypotheses generated by previous exploratory studies: changes in acylcarnitines and other intermediates of mitochondrial β-oxidation and the urea cycle, branched-chain amino acids and biogenic amines
  • 2. Metabolomics changes in urine [ Time Frame: From baseline to week 12 ]
    Targeted and quantitative analysis by ultra-high-resolution liquid chromatography coupled to triple quadrupole mass spectrometry (UHPL-QqQ/MS). Analysis of specific families of metabolites selected from hypotheses generated by previous exploratory studies: changes in acylcarnitines and other intermediates of mitochondrial β-oxidation and the urea cycle, branched-chain amino acids and biogenic amines
  • Secondary Outcome Measures: 1. BMI (body mass index) changes [ Time Frame: From baseline to to week 12 ]
    Measured by body composition analysis
  • 2. Changes in insulin resistance [ Time Frame: From baseline to to week 12 ]
    Measured as HOMA-IR (homeostatic model assessment of insulin resistance)
  • 3. Changes in metabolic control [ Time Frame: From baseline to to week 12 ]
    Measured as HbA1c (glycated hemoglobin)
  • 4. Changes in Quality of Life: 36-Item Short Form Health Survey (SF-36) questionnaire [ Time Frame: From baseline to to week 12 ]
    The SF-36 has eight scaled scores: physical functioning, role physical, bodily pain, general health, vitality, social functioning, role emotional, and mental health. The scores are weighted sums of the questions in each section. Scores range from 0 - 100, lower scores indicate more disability, and higher scores indicate less disability
  • 5. Changes in albuminuria [ Time Frame: From baseline to to week 12 ]
    Modifications in albuminuria, measured as albumin excretion rate (AER)
Eligibility Criteria
  • Ages Eligible for Study: 18 to 75 Years (Adult, Older Adult)
  • Sexes Eligible for Study: All
  • Accepts Healthy Volunteers: No
Criteria

Inclusion Criteria:

- Age 18-75.

- BMI 27-39.9 kg/m2.

- T2DM on treatment with metformin and inadequate metabolic control (defined as
HbA1c≥6.5 -7%).

Exclusion Criteria:

- Pregnancy (all women of child-bearing age, unless on treatment with contraceptive
methods, will undergo a pregnancy test)

- Breastfeeding

- Intolerance/allergy to dapagliflozin.

- Treatment with antidiabetic drug other than metformin.

- Impaired kidney function: Estimated glomerular filtration rate (eGFR) 2.0 mg / dl or GOT/GPT levels three times higher
than normal upper limit.

- Known HIV infection or active HBV or HCV infection.

- Other serious underlying diseases, which could affect the patient's ability to
participate in the study.

- Reduced life expectancy (<12 months) due to advanced or terminal concomitant diseases. In addition, female patients of child-bearing age will be advised to use contraceptive methods during the study period, given the contraindication of dapagliflozin and metformin during pregnancy as per normal clinical practice.

Contacts and Locations
Contacts

Contact: Jose Carlos Fernandez-Garcia, MD, PhD +34951034016 josecarlosfdezgarcia@hotmail.com

Locations

Spain
Virgen de la Victoria University Hospital. Endocrinology Department
Malaga

Sponsors and Collaborators

Fundación Pública Andaluza para la Investigación de Málaga en Biomedicina y Salud

Investigators

Principal Investigator: Jose Carlos Fernandez-Garcia, MD, PhD Virgen de la Victoria Hospital

More Information
  • Responsible Party: Fundación Pública Andaluza para la Investigación de Málaga en Biomedicina y Salud
  • ClinicalTrials.gov Identifier: NCT03919656 History of Changes
  • Other Study ID Numbers: FIM-DAPA-2018-01
  • First Posted: April 18, 2019 Key Record Dates
  • Last Update Posted: April 23, 2019
  • Last Verified: April 2019
  • Individual Participant
    Data (IPD) Sharing
    Statement:
  • Plan to Share IPD: No
  • Studies a U.S. FDA-regulated Drug Product: No
  • Studies a U.S. FDA-regulated Device Product: No
  • Product Manufactured in and Exported from the U.S.: Yes
  • Keywords provided by Fundación Pública Andaluza para la Investigación de Málaga en Biomedicina y Salud: Metabolomics Dapagliflozin
  • Additional relevant MeSH terms: Diabetes Mellitus, Type 2