Ignite Creation Date:
2024-06-16 @ 11:49 AM
Last Modification Date:
2024-10-26 @ 3:31 PM
Study NCT ID:
NCT06439758
Status:
NOT_YET_RECRUITING
Last Update Posted:
2024-06-03
First Post:
2024-05-20
Brief Title:
Effects of First-Line Oral Hypoglycemics in Bone Markers of Treatment Naïve Saudi Adults With Type 2 Diabetes
Sponsor:
King Saud University
Organization:
King Saud University
Study Overview
Official Title:
Effects of First-Line Oral Hypoglycemics in Bone Markers of Treatment Naïve Saudi Adults With Type 2 Diabetes
Status:
NOT_YET_RECRUITING
Status Verified Date:
2024-05
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
Both diabetes mellitus and osteoporosis are prevalent diseases with crucial associated mortality and morbidity There is no clear relevance between bone diseases and diabetes mellitus Previous research indicates that diabetes and complications related to this disease can contribute to bone disease and DM can also determine bone health Both kinds of diabetes mellitus bring fracture risk the most substantial clinical osteoporosis endpoint which has crucial impact on mortality and morbidity including quality of life of an individual Although research shows that there is association between Type 1 diabetes T1DM and decreased bone mineral density BMD values patients with Type 2 diabetes T2DM have either normal or higher than expected BMD values usually General Objective To determine the influence of first-line anti-DM therapies in bone turnover markers and metabolism among T2DM naïve Saudi adults
Specific objectives
To investigate the differences in the 3- and 6-month effects of metformin alone lifestyle intervention alone and combination metformin lifestyle modification on bone markers in T2DM naïve Saudi adults
To investigate the differences in the 3- and 6-month effects of metformin alone lifestyle intervention alone and combination metformin lifestyle modification on metabolism in T2DM naïve Saudi adults
Specific objectives
To investigate the differences in the 3- and 6-month effects of metformin alone lifestyle intervention alone and combination metformin lifestyle modification on bone markers in T2DM naïve Saudi adults
To investigate the differences in the 3- and 6-month effects of metformin alone lifestyle intervention alone and combination metformin lifestyle modification on metabolism in T2DM naïve Saudi adults
Detailed Description:
Design and Setting The present investigation is a multi-center intervention study to be conducted in Hail Saudi Arabia The primary endpoint of the study is changes in bone markers
Participants
Consenting Saudi adults males and females aged 25-65 years with newly diagnosed T2DM will be included T2DM diagnosis will be done by collaborating primary care physicians following the American Diabetes Association ADA and World Health Organization WHO criteria
Fasting plasma glucose 70mmoll or 126mgdl Fasting is defined as no caloric intake for at least 8 hours OR
2-h PG 200 mgdl 111 mmolL during OGTT The test should be performed as described by WHO using a glucose load containing the equivalent of 75g anhydrous glucose dissolved in water
OR Hba1c 65 48 mmolmol The test should be performed in a laboratory using a method that is National Glycohemoglobin Standardization Program NGSP certified and standardized to the Diabetes Control and Complications Trial DCCT assay
OR
In a patient with classic symptoms of hyperglycemia or hyperglycemic crisis a random plasma glucose 200 mgdl 111 mmolL
Exclusion Criteria
Non-Saudis and those outside the age range less than 25 years and above 65 years old
Those with comorbidities and existing complications osteoporosis uncontrolled hypertension atherosclerosis renal and liver abnormalities morbidly obese psychologically incapacitated
Known cases of T2DM who are already on medications
Participants who will be unable to commit to the treatment allocated for 6 months either for personal reasons or physicians advice
Intervention
Participants will be assigned to receive for 6 months either A Metformin 500mgday B Lifestyle Modification or C Metformin Lifestyle Modification The lifestyle modification management was based on a T2DM prevention program for people with prediabetes and includes weight reduction to 5 from baseline moderate exercise 150minweek reduction of fat intake and increased fiber intake 15g1000kcal Monitoring will be done at baseline after 3 months and after 6 months Below is the schematic diagram of the study
Figure 1 Schematic diagram of the intervention study
Data Collection A generalized questionnaire will be administered to patients at baseline which includes demographics medical history and risk for osteoporosis
Anthropometrics Height cm and weight kg will be measured with the participant wearing light clothing Waist cm and hip cm circumferences will be measured using standard tape measure Blood pressure mmHg will be measured using a digital sphygmomanometer twice at 15min interval and the average will be recorded
Sample Collection Fasting blood samples will be collected from participants at baseline and follow-up visits Routine blood tests GlucoseHbA1c liver function tests renal function tests and lipid profile will be done at primary healthcare will be measured using the ARCHITECT c4000 clinical chemistry analyzer and Abbott Afinion HbA1c analyzer For the bone markers CTX PINP Sclerostin and Osteocalcin will be sent to the Chair for Biomarkers of Chronic Diseases CBCD in King Saud University Riyadh Saudi Arabia for testing using the enzyme-linked immunosorbent assay ELISA CTX and PINP will be measured using Cobas e411 immunoassay analyzer Sclerostin and Osteocalcin NMIDwill be measured using commercially available assays
Sample size calculation Mori et al 2017 have reported the significant decrease in CTX after 3-months in participants consuming metformin as compared to participants consuming pioglitazone with the effect size of 040 In our study to determine the significant change in BTM with the effect size of 030 with the power of 80 the required total sample size would be 111 at 95 CI divided in 3 groups N37 per group We intend to recruit 40 participants or more per group to account for dropouts
Data Analysis Data analysis will be done using SPSS version 21 Chicago IL USA Statistical analysis will be performed using Intent-to-Treat analysis All normally distributed data will be presented as mean and standard deviations while non-normally distributed data will be presented as median and interquartile range Categorical data will be presented as frequencies and percentages Analysis of Variance ANOVA and Kruskal Wallis tests will be used to compare significant baseline differences between groups Log transformation will be used to transform non-normal variables prior to repeated measure analysis of variance ANOVA which will be used to obtain within group differences Logistic regression analysis showing odds of improvement in bone markers as well as other variables of interest in groups will be calculated A p-value 005 was considered statistically significant
Participants
Consenting Saudi adults males and females aged 25-65 years with newly diagnosed T2DM will be included T2DM diagnosis will be done by collaborating primary care physicians following the American Diabetes Association ADA and World Health Organization WHO criteria
Fasting plasma glucose 70mmoll or 126mgdl Fasting is defined as no caloric intake for at least 8 hours OR
2-h PG 200 mgdl 111 mmolL during OGTT The test should be performed as described by WHO using a glucose load containing the equivalent of 75g anhydrous glucose dissolved in water
OR Hba1c 65 48 mmolmol The test should be performed in a laboratory using a method that is National Glycohemoglobin Standardization Program NGSP certified and standardized to the Diabetes Control and Complications Trial DCCT assay
OR
In a patient with classic symptoms of hyperglycemia or hyperglycemic crisis a random plasma glucose 200 mgdl 111 mmolL
Exclusion Criteria
Non-Saudis and those outside the age range less than 25 years and above 65 years old
Those with comorbidities and existing complications osteoporosis uncontrolled hypertension atherosclerosis renal and liver abnormalities morbidly obese psychologically incapacitated
Known cases of T2DM who are already on medications
Participants who will be unable to commit to the treatment allocated for 6 months either for personal reasons or physicians advice
Intervention
Participants will be assigned to receive for 6 months either A Metformin 500mgday B Lifestyle Modification or C Metformin Lifestyle Modification The lifestyle modification management was based on a T2DM prevention program for people with prediabetes and includes weight reduction to 5 from baseline moderate exercise 150minweek reduction of fat intake and increased fiber intake 15g1000kcal Monitoring will be done at baseline after 3 months and after 6 months Below is the schematic diagram of the study
Figure 1 Schematic diagram of the intervention study
Data Collection A generalized questionnaire will be administered to patients at baseline which includes demographics medical history and risk for osteoporosis
Anthropometrics Height cm and weight kg will be measured with the participant wearing light clothing Waist cm and hip cm circumferences will be measured using standard tape measure Blood pressure mmHg will be measured using a digital sphygmomanometer twice at 15min interval and the average will be recorded
Sample Collection Fasting blood samples will be collected from participants at baseline and follow-up visits Routine blood tests GlucoseHbA1c liver function tests renal function tests and lipid profile will be done at primary healthcare will be measured using the ARCHITECT c4000 clinical chemistry analyzer and Abbott Afinion HbA1c analyzer For the bone markers CTX PINP Sclerostin and Osteocalcin will be sent to the Chair for Biomarkers of Chronic Diseases CBCD in King Saud University Riyadh Saudi Arabia for testing using the enzyme-linked immunosorbent assay ELISA CTX and PINP will be measured using Cobas e411 immunoassay analyzer Sclerostin and Osteocalcin NMIDwill be measured using commercially available assays
Sample size calculation Mori et al 2017 have reported the significant decrease in CTX after 3-months in participants consuming metformin as compared to participants consuming pioglitazone with the effect size of 040 In our study to determine the significant change in BTM with the effect size of 030 with the power of 80 the required total sample size would be 111 at 95 CI divided in 3 groups N37 per group We intend to recruit 40 participants or more per group to account for dropouts
Data Analysis Data analysis will be done using SPSS version 21 Chicago IL USA Statistical analysis will be performed using Intent-to-Treat analysis All normally distributed data will be presented as mean and standard deviations while non-normally distributed data will be presented as median and interquartile range Categorical data will be presented as frequencies and percentages Analysis of Variance ANOVA and Kruskal Wallis tests will be used to compare significant baseline differences between groups Log transformation will be used to transform non-normal variables prior to repeated measure analysis of variance ANOVA which will be used to obtain within group differences Logistic regression analysis showing odds of improvement in bone markers as well as other variables of interest in groups will be calculated A p-value 005 was considered statistically significant
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None