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COMPLETEDPHASE4

Effects of 2 Weeks Treatment With Dapagliflozin in Subjects With an Impaired Glucose Homeostasis on Nocturnal Substrate Oxidation

MaasFlex: Double-Blind, Randomized, Phase IV, Mechanistic, Placebo-Controlled, Cross-Over, Single-Center Study to Evaluate the Effects of 2 Weeks Dapagliflozin Treatment on Nocturnal Substrate Oxidation, Glucose Metabolism and Muscle Mitochondrial Function in Individuals With Impaired Glucose Homeostasis

NCT03721874•Maastricht University

View on ClinicalTrials.gov

Summary

The purpose of this study is to investigate the effect of 2 weeks dapagliflozin treatment in individuals with a disrupted glucose homeostasis on the switch between carbohydrate and lipid oxidation during the night

Detailed Description

To investigate if dapagliflozin improves nocturnal substrate oxidation expressed as respiration quotient (RQ) during the sleeping period in comparison with placebo after 2-weeks double blind treatment in subjects with a disrupted glucose homeostasis.

Eligibility

Age

40 - 75 years

Sex

ALL

Healthy Volunteers

Yes

Inclusion Criteria

•1. Provision of signed and dated informed consent prior to any study specific procedures.
•2. Males aged ≥ 40 and ≤ 75 years and post-menopausal women (defined as at least 1 year post cessation of menses) aged ≥ 50 and ≤ 75 years
•3. Body mass index (BMI) ≥ 27 and ≤ 38 kg/m2.
•4. Sedentary lifestyle (not more than 3 hours of programmed exercise per week).
•5. Stable dietary habits.
•6. Impaired glucose homeostasis based on one or a combination of the following criteria:
•* Impaired Glucose Tolerance (IGT): plasma glucose values ≥ 7.8 mmol/l and ≤ 11.1 mmol/l 120 minutes after consumption of the glucose drink during the 2h, 3-point OGTT.
•* Impaired Fasting Glucose (IFG): fasting plasma glucose ≥ 6.1 mmol/l and ≤ 6.9 mmol/l.
•* Insulin Resistance: glucose clearance rate ≤ 360 ml/kg/min, as calculated by Oral Glucose Insulin Sensitivity 120 (OGIS120) model based on the 2h, 3-point OGTT.
•* HbA1c ≥ 5.7% and ≤ 6.4%.

Exclusion Criteria

•1. Clinical diagnosis of Type 1 or 2 Diabetes Mellitus.
•2. Active cardiovascular disease: participants who experienced a heart attack in the last year, or participants who are currently under regular control of a physician for a heart condition.
•3. Weight gain or loss \> 5 kg in the last 3 months, ongoing weight-loss diet (hypocaloric diet) or use of weight loss agents.
•4. Regular smoking and other regular nicotine use.
•5. Anaemia.
•6. Uncontrolled hypertension.
•7. Clinically significant out of range values of serum levels of either alanine aminotransferase (ALT), aspartate aminotransferase (AST), alkaline phosphatase (ALP) in the Investigator's opinion.
•8. Unstable or rapidly progressing renal disease or estimated Glomerular Filtration Rate (eGFR) \<60 mL/min (Cockcroft-Gault formula).
•9. Use of anti-coagulant treatment and other concomitant medication will be evaluated on a case to case basis with a general physician.
•10. Use of medication such as oral glucocorticoids, anti-estrogens or other medications that are known to markedly influence insulin sensitivity.
+8 more criteria

Locations (1)

Maastricht University and Medical Centre

Maastricht, Limburg, Netherlands

Key Dates

Start Date

April 30, 2019

Primary Completion Date

June 29, 2021

Completion Date

June 29, 2021

Last Updated

August 19, 2021

Enrollment

ACTUAL participants

Conditions

Prediabetic StateSubstrate Oxidation

Interventions

Dapagliflozin 10mg

DRUG

Placebo matching to Dapagliflozin 10 mg

DRUG

Role of Aging and Individual Variation in Exercise Training Responsiveness

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Prediabetic StateCardiovascular Diseases+2 more

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RECRUITINGNA

PreventT2 Together: Examining the Efficacy of Couple-based Lifestyle Intervention to Prevent Type 2 Diabetes

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Prediabetic StateLife Style+4 more

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Data Source & Attribution

This clinical trial information is sourced from ClinicalTrials.gov, a service of the U.S. National Institutes of Health.

ClinicalTrials.gov last update: August 19, 2021Data synced to Clareo: March 29, 2026

Modifications: This data has been reformatted for display purposes. Eligibility criteria have been parsed into inclusion/exclusion sections. Location data has been geocoded to enable distance-based search. For the authoritative and most current information, please visit ClinicalTrials.gov.

Neither the United States Government nor Clareo Health make any warranties regarding the data. Check ClinicalTrials.gov frequently for updates.

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Effects of 2 Weeks Treatment With Dapagliflozin in Subjects With an Impaired Glucose Homeostasis on Nocturnal Substrate Oxidation

Inclusion Criteria

Exclusion Criteria

Role of Aging and Individual Variation in Exercise Training Responsiveness

PreventT2 Together: Examining the Efficacy of Couple-based Lifestyle Intervention to Prevent Type 2 Diabetes

Effect of Zinc on Glucose Homeostasis

Exercise Training and Fat Metabolism in Postmenopausal Women

Efficacy of High-intensity Exercise in Women With Prediabetes

Effect of Insulin Lowering on Lipogenesis