Pre-diabetes in women of South Asian ethnicity. Women of South Asian ethnicity with previous gestational diabetes, where pre-diabetes in the form of impaired glucose tolerance or impaired fasting glucose has been found 1-3 years after childbirth. MedDRA version: 20.1 Level: LLT Classification code 10036481 Term: Pre-diabetes System Organ Class: 100000004861
Conditions
Interventions
Trade Name: Metformin Karo Pharma
Product Name: Metformin
Pharmaceutical Form: Capsule
Trade Name: Actos
Product Name: Pioglitazone
Sponsors
Oslo University Hospital
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: Inclusion Criteria Able and willing to give an informed consent Woman = 18 years of age Of South Asian origin Participated in the DIASA 1 study of women with previous gestational diabetes 1-3 years after childbirth. Impaired glucose tolerance and/or impaired fasting glucose in DIASA 1 Are the trial subjects under 18? no Number of subjects for this age range: F.1.2 Adults (18-64 years) yes F.1.2.1 Number of subjects for this age range 324 F.1.3 Elderly (>=65 years) no F.1.3.1 Number of subjects for this age range
Exclusion criteria
Exclusion criteria: Exclusion Criteria Known type 2 diabetes Known type 1 diabetes Not willing to give informed consent Pregnant or lactating at randomisation or planned during study period. Not willing to practice a highly effective birth control method prior to initial dose, during study and for 2 weeks after the last administration of study drug. Concomitant use of any antidiabetic medication Concomitant use of fibrates or rifampicine Radiological examinations using iodine containing contrast the previous week before randomisation, or planned during the study period. Known serious illness such as cancer (except in situ carcinoma) during past 5 years. Previous radiation therapy directed towards the pelvic area. Heart failure NYHA class I-IV. eGFR 5 x ULN Active infectious disease at inclusion Use of systemic corticosteroids > 14 days within last 3 months before inclusion Hypothyroidism where Levaxin treatment has not been stable for the last 3 months or with TSH outside normal limits. A history of bullous pemphigoid A history of acute or chronic pancreatitis Macroscopic haematuria not previously examined History of major surgical procedures within 3 months prior to inclusion or planned during study period. Any condition which in the investigator's opinion would jeopardize the subject's safety or compliance with the protocol.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: Primary aim: To identify which oral glucose lowering agent(s) is/are most effective in treating impaired glucose metabolism in South Asians (SA). ; Primary end point(s): Primary end point: Change in basal and clamp endogenous glucose production (EGP) from baseline to 12 weeks. ; Secondary Objective: Secondary aims: To identify the medication(s) to test further in the DIASA 6 intervention trial in SA with established T2D. To explore the overall effect of each of four different oral antidiabetic drugs in SA women with Impaired Glucose Tolerance (IGT)/Impaired Fasting Glucose (IFG) by examining parameters of: - Glucose metabolism: basal Endogenous Glucose Production (EGP), clamp measured EGP and total glucose disposal at each clamp step, fasting plasma glucose and insulin, HbA1c, glucose oxidation and non-oxidative glucose metabolism. - Lipid metabolism: Fasting lipids, lipid oxidation, hepatic and pancreatic lipid content, visceral adipose tissue, lipidomic patterns. To identify possible interactions between variants in candidate genes, their relationship to liver fat, EGP and the efficacy of antidiabetic treatment in SA. ;Timepoint(s) of evaluation of this end point: Primary end point will be evaluated at 12 weeks. | — |
Secondary
| Measure | Time frame |
|---|---|
| Timepoint(s) of evaluation of this end point: Secondary end points will be evaluated at 12 weeks. ; Secondary end point(s): Secondary end points: Difference in change in whole body insulin sensitivity from randomisation to 12 weeks between treatment arms. Difference in change in HbA1c between treatment arms. Difference in glucose and lipid metabolism measured by Indirect Calorimetry between treatment arms. Difference in fatty infiltration in liver and visceral adipose tissue between treatment arms. | — |
Countries
Norway
Contacts
Public ContactDIASA Research Manager C Wium
Oslo University Hospital
Outcome results
None listed