| Trial ID: | L1849 |
| Source ID: | NCT04662866
|
| Associated Drug: |
Metformin Capsule 500 Mg, Empagliflozin Encapsulated Tablet 10 Mg, Pioglitazone Encapsulated Tablet 30 Mg, Linagliptin Encapsulated Tablet 5 Mg
|
| Title: |
Effects of Glucose Lowering Agents in South Asian Women With Impaired Glucose Tolerance or Impaired Fasting Glucose
|
| Acronym: |
DIASA3
|
| Status: |
UNKNOWN
|
| Study Results: |
NO
|
| Results: |
|
| Conditions: |
Impaired Glucose Tolerance|Insulin Sensitivity|Glucose Metabolism Disorders
|
| Interventions: |
DRUG: Metformin capsule 500 mg, Empagliflozin encapsulated tablet 10 mg, Pioglitazone encapsulated tablet 30 mg, Linagliptin encapsulated tablet 5 mg
|
| Outcome Measures: |
Primary: Endogenous glucose production during fasting, Difference between treatment arms in change from baseline to 12 weeks in endogenous glucose production during fasting measured by the deuterated glucose tracer dilution method in umol/(kg fat free mass x minutes), After 12 weeks on respective drugs | Other: Endogenous glucose production during hyperinsulinemia, Difference between treatment arms in change from baseline to 12 weeks in endogenous glucose production measured by the deuterated glucose tracer dilution method during euglycaemic clamp in umol/(kg fat free mass x minutes), After 12 weeks on respective drugs|Whole body insulin sensitivity, Difference between treatment arms in change from baseline to 12 weeks in whole body insulin sensitivity measured by euglycemic clamp derived total glucose disposal in umol/(kg fat free mass x minutes), After 12 weeks on respective drugs|Insulin secretion, Difference between treatment arms in change in insulin secretion from baseline to 12 weeks, measured by the insulinogenic index, i.e. the change in serum insulin (pmol/l) from 0 to 30 min divided by the change in plasma glucose (mmol/l) from 0 to 30 minutes of an oral glucose tolerance test., After 12 weeks on respective drugs|Liver fat, Explore the difference between treatment arms in change in fatty infiltration in the liver measured as the attenuation in CT-measured regions of interest from baseline to 12 weeks., After 12 weeks on respective drugs|Glycemia, Difference between treatment arms in change in HbA1c in mmol/mol from baseline to 12 weeks ., After 12 weeks on respective drugs|Pancreatic fat, Explore the difference between treatment arms in change in fatty infiltration of the pancreas measured as the attenuation in CT-measured regions of interest, After 12 weeks on respective drugs|Intraabdominal fat, Explore the difference between treatment arms in change in visceral fat volume, in cubic centimeters, from baseline to 12 weeks, on abdominal CT scans running from the top of the diaphragm to the iliac crest., After 12 weeks on respective drugs
|
| Sponsor/Collaborators: |
Sponsor: Oslo University Hospital | Collaborators: The Research Council of Norway|Norwegian Diabetes Association|South-Eastern Norway Regional Health Authority|University of Oslo|University Hospital, Akershus|Vestre Viken Hospital Trust|University of Glasgow
|
| Gender: |
FEMALE
|
| Age: |
ADULT
|
| Phases: |
PHASE2
|
| Enrollment: |
64
|
| Study Type: |
INTERVENTIONAL
|
| Study Designs: |
Allocation: RANDOMIZED|Intervention Model: PARALLEL|Masking: QUADRUPLE (PARTICIPANT, CARE_PROVIDER, INVESTIGATOR, OUTCOMES_ASSESSOR)|Primary Purpose: TREATMENT
|
| Start Date: |
2021-02-10
|
| Completion Date: |
2023-10
|
| Results First Posted: |
|
| Last Update Posted: |
2021-04-08
|
| Locations: |
Oslo University Hospital, Aker Hospital, Oslo, 0424, Nydalen, Norway
|
| URL: |
https://clinicaltrials.gov/show/NCT04662866
|
