Abdominal ObesityNCT05032001
ORAL ANTIDIABETICS EFFECT ON VISCERAL FAT
A study testing Biguanide, DPP4 inhibitors, SGLT2 inhibitors in people with Abdominal Obesity and Type 2 Diabetes, run by Metabolic Research Unit at 1 site in Mexico.
Trial summary
Weight control is an essential part of treatment for type 2 diabetes (T2D) patients. Weight loss is associated with decreased haemoglobin A1c (A1c) levels. In particular, visceral fat is accompanied by more alterations in glucose and lipid metabolism. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Abdominal Obesity, Type 2 Diabetes
- What is being tested?
- Biguanide, DPP4 inhibitors, SGLT2 inhibitors
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 30 participants
- Where
- 1 siteMexico
- Study dates
- 1 Aug 2021to 1 Aug 2022
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Adult patients +18 years
- Patients with visceral fat quantification by BIA at baseline and week twelve
- Patients with body mass index >25
- Patients can swallow tablets
Who cannot join
- Patients treated with other oral antidiabetic agents or insulin
- Glomerular filtration rate less than 30 mL/min
- Transaminemia greater than 2 times the upper reference value
- Pregnancy
- Malnutrition
Trial locations and contacts
1 site in 1 country.
About this study
Official title: ORAL ANTIDIABETICS EFFECT ON VISCERAL FAT MEASURED BY BIOIMPEDANCE IN TYPE 2 DIABETES PATIENTS. Pilot Study.
Weight control is an essential part of treatment for type 2 diabetes (T2D) patients. Weight loss is associated with decreased haemoglobin A1c (A1c) levels. In particular, visceral fat is accompanied by more alterations in glucose and lipid metabolism. Quantification of visceral fat with bioimpedance (BIA) is closely related to measurement with computed axial tomography. Different available oral antidiabetics cause weight loss and total body fat (biguanides, DPP-4 inhibitors and SGLT-2 inhibitors), but it has only been shown that SLGT2 inhibitors decrease visceral fat. Therefore, the aim of this study is to determine whether there is a difference in the amount of visceral fat measured with BIA in T2D patients between three oral antidiabetic regimens after twelve weeks of treatment, to compare the effect on visceral fat between metformin, DPP4 inhibitors and SGLT2 inhibitors.
- Conditions
- Abdominal Obesity, Type 2 Diabetes
- Being tested
- Biguanide, DPP4 inhibitors, SGLT2 inhibitors
- Medical subject headings
- Obesity, Abdominal, Diabetes Mellitus, Type 2
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Biguanide, DPP4 inhibitors, SGLT2 inhibitorsDrug
Oral antidiabetic treatment during twelve weeks
| Study group | Role | What they receive |
|---|---|---|
| Metformin | Experimental | Metformin 1.7-2.5mg per day during twelve weeks Receives: Drug: Biguanide, DPP4 inhibitors, SGLT2 inhibitors |
| Metformina + IDDP-4 | Experimental | Metformin 1.7-2.5mg per day plus Linagliptin 5mg per day or Sitagliptin 50-100mg per day Receives: Drug: Biguanide, DPP4 inhibitors, SGLT2 inhibitors |
| Metformina + ISGLT-2 | Experimental | Metformin 1.7-2.5mg per day plus Empaglifozin 10-25mg per day or Dapaglifozin 10mg per day Receives: Drug: Biguanide, DPP4 inhibitors, SGLT2 inhibitors |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change from baseline in visceral fat measured by bioimpedance in kg at weet twelve
Bioimpedance is a confident method to measured visceral fat
Measured: Baseline and week twelve
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted2 Sep 2021
- Study start1 Aug 2021
- Primary completion1 Aug 2022 (estimated)
- Study completion1 Aug 2022 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (8)Papers the sponsor has linked to this study.
- Other trials for Abdominal ObesityStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 30 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Metabolic Research Unit
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Principal investigator, Alonso Alberto Castro Arguelles, Metabolic Research Unit
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05032001
- Sponsor's protocol ID
- protocol1
- Status last verified
- Sep 2021
- First submitted
- 21 Aug 2021
- Last updated
- 9 Sep 2021
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Publications
Lee DH, Park KS, Ahn S, Ku EJ, Jung KY, Kim YJ, Kim KM, Moon JH, Choi SH, Park KS, Jang HC, Lim S. Comparison of Abdominal Visceral Adipose Tissue Area Measured by Computed Tomography with That Estimated by Bioelectrical Impedance Analysis Method in Korean Subjects. Nutrients. 2015 Dec 16;7(12):10513-24. doi: 10.3390/nu7125548.
PubMed 26694460Park KS, Lee DH, Lee J, Kim YJ, Jung KY, Kim KM, Kwak SH, Choi SH, Park KS, Jang HC, Lim S. Comparison between two methods of bioelectrical impedance analyses for accuracy in measuring abdominal visceral fat area. J Diabetes Complications. 2016 Mar;30(2):343-9. doi: 10.1016/j.jdiacomp.2015.10.014. Epub 2015 Oct 24.
PubMed 26620129Golay A. Metformin and body weight. Int J Obes (Lond). 2008 Jan;32(1):61-72. doi: 10.1038/sj.ijo.0803695. Epub 2007 Jul 24.
PubMed 17653063Nauck MA, Meininger G, Sheng D, Terranella L, Stein PP; Sitagliptin Study 024 Group. Efficacy and safety of the dipeptidyl peptidase-4 inhibitor, sitagliptin, compared with the sulfonylurea, glipizide, in patients with type 2 diabetes inadequately controlled on metformin alone: a randomized, double-blind, non-inferiority trial. Diabetes Obes Metab. 2007 Mar;9(2):194-205. doi: 10.1111/j.1463-1326.2006.00704.x.
PubMed 17300595Bolinder J, Ljunggren O, Kullberg J, Johansson L, Wilding J, Langkilde AM, Sugg J, Parikh S. Effects of dapagliflozin on body weight, total fat mass, and regional adipose tissue distribution in patients with type 2 diabetes mellitus with inadequate glycemic control on metformin. J Clin Endocrinol Metab. 2012 Mar;97(3):1020-31. doi: 10.1210/jc.2011-2260. Epub 2012 Jan 11.
PubMed 22238392Sugiyama S, Jinnouchi H, Kurinami N, Hieshima K, Yoshida A, Jinnouchi K, Nishimura H, Suzuki T, Miyamoto F, Kajiwara K, Jinnouchi T. Dapagliflozin Reduces Fat Mass without Affecting Muscle Mass in Type 2 Diabetes. J Atheroscler Thromb. 2018 Jun 1;25(6):467-476. doi: 10.5551/jat.40873. Epub 2017 Dec 8.
PubMed 29225209Schork A, Saynisch J, Vosseler A, Jaghutriz BA, Heyne N, Peter A, Haring HU, Stefan N, Fritsche A, Artunc F. Effect of SGLT2 inhibitors on body composition, fluid status and renin-angiotensin-aldosterone system in type 2 diabetes: a prospective study using bioimpedance spectroscopy. Cardiovasc Diabetol. 2019 Apr 5;18(1):46. doi: 10.1186/s12933-019-0852-y.
PubMed 30953516Whitehead AL, Julious SA, Cooper CL, Campbell MJ. Estimating the sample size for a pilot randomised trial to minimise the overall trial sample size for the external pilot and main trial for a continuous outcome variable. Stat Methods Med Res. 2016 Jun;25(3):1057-73. doi: 10.1177/0962280215588241. Epub 2015 Jun 19.
PubMed 26092476
Study at a glance
From the registry record, last updated by the sponsor on 9 Sep 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- ORAL ANTIDIABETICS EFFECT ON VISCERAL FAT MEASURED BY BIOIMPEDANCE IN TYPE 2 DIABETES PATIENTS. Pilot Study.
- ClinicalTrials.gov ID
- NCT05032001
- Acronym / sponsor ID
- protocol1
- Conditions
- Abdominal Obesity, Type 2 Diabetes
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 30 participants (estimated)
- Lead sponsor
- Metabolic Research UnitIndustry (pharma, biotech, devices)
- Study start
- 1 Aug 2021 (actual)
- Primary completion
- 1 Aug 2022 (estimated)
- Study completion
- 1 Aug 2022 (estimated)
- First posted
- 2 Sep 2021 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
Weight control is an essential part of treatment for type 2 diabetes (T2D) patients. Weight loss is associated with decreased haemoglobin A1c (A1c) levels. In particular, visceral fat is accompanied by more alterations in glucose and lipid metabolism. Quantification of visceral fat with bioimpedance (BIA) is closely related to measurement with computed axial tomography. Different available oral antidiabetics cause weight loss and total body fat (biguanides, DPP-4 inhibitors and SGLT-2 inhibitors), but it has only been shown that SLGT2 inhibitors decrease visceral fat. Therefore, the aim of this study is to determine whether there is a difference in the amount of visceral fat measured with BIA in T2D patients between three oral antidiabetic regimens after twelve weeks of treatment, to compare the effect on visceral fat between metformin, DPP4 inhibitors and SGLT2 inhibitors.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Metformin | Experimental | Drug: Biguanide, DPP4 inhibitors, SGLT2 inhibitorsMetformin 1.7-2.5mg per day during twelve weeks |
| Metformina + IDDP-4 | Experimental | Drug: Biguanide, DPP4 inhibitors, SGLT2 inhibitorsMetformin 1.7-2.5mg per day plus Linagliptin 5mg per day or Sitagliptin 50-100mg per day |
| Metformina + ISGLT-2 | Experimental | Drug: Biguanide, DPP4 inhibitors, SGLT2 inhibitorsMetformin 1.7-2.5mg per day plus Empaglifozin 10-25mg per day or Dapaglifozin 10mg per day |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- Adult patients +18 years
- Patients with visceral fat quantification by BIA at baseline and week twelve
- Patients with body mass index >25
- Patients can swallow tablets
Key exclusion criteria (5 listed)
- Patients treated with other oral antidiabetic agents or insulin
- Glomerular filtration rate less than 30 mL/min
- Transaminemia greater than 2 times the upper reference value
- Pregnancy
- Malnutrition
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Biguanide, DPP4 inhibitors, SGLT2 inhibitorsOral antidiabetic treatment during twelve weeks | Drug | Metformin, Metformina + IDDP-4, Metformina + ISGLT-2 |
Primary outcome
Change from baseline in visceral fat measured by bioimpedance in kg at weet twelve
Time frame: Baseline and week twelve
Bioimpedance is a confident method to measured visceral fat
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 9 Sep 2021.
- Background: PubMed 26694460Lee DH, Park KS, Ahn S, Ku EJ, Jung KY, Kim YJ, Kim KM, Moon JH, Choi SH, Park KS, Jang HC, Lim S. Comparison of Abdominal Visceral Adipose Tissue Area Measured by Computed Tomography with That Estimated by Bioelectrical Impedance Analysis Method in Korean Subjects. Nutrients. 2015 Dec 16;7(12):10513-24. doi: 10.3390/nu7125548.
- Background: PubMed 26620129Park KS, Lee DH, Lee J, Kim YJ, Jung KY, Kim KM, Kwak SH, Choi SH, Park KS, Jang HC, Lim S. Comparison between two methods of bioelectrical impedance analyses for accuracy in measuring abdominal visceral fat area. J Diabetes Complications. 2016 Mar;30(2):343-9. doi: 10.1016/j.jdiacomp.2015.10.014. Epub 2015 Oct 24.
- Background: PubMed 17653063Golay A. Metformin and body weight. Int J Obes (Lond). 2008 Jan;32(1):61-72. doi: 10.1038/sj.ijo.0803695. Epub 2007 Jul 24.
- Background: PubMed 17300595Nauck MA, Meininger G, Sheng D, Terranella L, Stein PP; Sitagliptin Study 024 Group. Efficacy and safety of the dipeptidyl peptidase-4 inhibitor, sitagliptin, compared with the sulfonylurea, glipizide, in patients with type 2 diabetes inadequately controlled on metformin alone: a randomized, double-blind, non-inferiority trial. Diabetes Obes Metab. 2007 Mar;9(2):194-205. doi: 10.1111/j.1463-1326.2006.00704.x.
- Background: PubMed 22238392Bolinder J, Ljunggren O, Kullberg J, Johansson L, Wilding J, Langkilde AM, Sugg J, Parikh S. Effects of dapagliflozin on body weight, total fat mass, and regional adipose tissue distribution in patients with type 2 diabetes mellitus with inadequate glycemic control on metformin. J Clin Endocrinol Metab. 2012 Mar;97(3):1020-31. doi: 10.1210/jc.2011-2260. Epub 2012 Jan 11.
- Background: PubMed 29225209Sugiyama S, Jinnouchi H, Kurinami N, Hieshima K, Yoshida A, Jinnouchi K, Nishimura H, Suzuki T, Miyamoto F, Kajiwara K, Jinnouchi T. Dapagliflozin Reduces Fat Mass without Affecting Muscle Mass in Type 2 Diabetes. J Atheroscler Thromb. 2018 Jun 1;25(6):467-476. doi: 10.5551/jat.40873. Epub 2017 Dec 8.
- Background: PubMed 30953516Schork A, Saynisch J, Vosseler A, Jaghutriz BA, Heyne N, Peter A, Haring HU, Stefan N, Fritsche A, Artunc F. Effect of SGLT2 inhibitors on body composition, fluid status and renin-angiotensin-aldosterone system in type 2 diabetes: a prospective study using bioimpedance spectroscopy. Cardiovasc Diabetol. 2019 Apr 5;18(1):46. doi: 10.1186/s12933-019-0852-y.
- Background: PubMed 26092476Whitehead AL, Julious SA, Cooper CL, Campbell MJ. Estimating the sample size for a pilot randomised trial to minimise the overall trial sample size for the external pilot and main trial for a continuous outcome variable. Stat Methods Med Res. 2016 Jun;25(3):1057-73. doi: 10.1177/0962280215588241. Epub 2015 Jun 19.
- Individual participant dataSharing planned: Undecided
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Biguanide, DPP4 inhibitors, SGLT2 inhibitors in people with Abdominal Obesity and Type 2 Diabetes, run by Metabolic Research Unit at 1 site in Mexico.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 9 Sep 2021. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Mexico. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change from baseline in visceral fat measured by bioimpedance in kg at weet twelve (time frame: Baseline and week twelve). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT05032001, which also lists 8 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 9 Sep 2021.