An observational study in Diabetes Type 2, sponsored by Instituto Nacional de Ciencias Medicas y Nutricion Salvador Zubiran. Recruiting at 1 site in Mexico. Open to participants aged 18 Years to 65 Years. Per ClinicalTrials.gov, last updated 2026-08-12.
Sponsored by Instituto Nacional de Ciencias Medicas y Nutricion Salvador Zubiran · Observational
Among 10 studies in Diabetes Mellitus, Type 2 by Instituto Nacional de Ciencias Medicas y Nutricion Salvador Zubiran — 3 open to participants now, 5 under way, none of them phase 3. Diabetes Mellitus, Type 2 · Instituto Nacional de Ciencias Medicas y Nutricion Salvador Zubiran.
Among the 10 studies in Diabetes Mellitus, Type 2 by Instituto Nacional de Ciencias Medicas y Nutricion Salvador Zubiran, this one is the only one that started in 2020, is one of 2 observational ones, and was the 9th registered.
10,371 studies on the registry are indexed under Diabetes Mellitus, Type 2; 1,406 are open to participants now.
This study's planned enrollment of 154 is below the median of 300 across 1,741 observational studies indexed under Diabetes Mellitus, Type 2.
Browse Diabetes Mellitus, Type 2 studies →3 of the 10 studies in Diabetes Mellitus, Type 2 by Instituto Nacional de Ciencias Medicas y Nutricion Salvador Zubiran are open now, in 1 country. Each count lists the studies.
Of the 883 Diabetes Mellitus, Type 2 studies recruiting now, 373 (42%) set no upper age limit and 384 (43%) stop at 75 or younger; 52 take children under 18; 203 take healthy volunteers.
This study: 18 Years to 65 Years · all sexes · no healthy volunteers.
The full table on the hub →10 studies; the count open now beside each. This study's row is marked.
First in 2011; this study’s year is marked. 1 started in 2020.
Median enrollment 83 across the 8 interventional studies, 177 across the 2 observational. Of the 4 that completed or were terminated, 1 (25%) have results posted.
Instituto Nacional de Ciencias Medicas y Nutricion Salvador Zubiran is the lead sponsor of 144 studies on the registry; 16 are open to participants now.
2 of the studies in Diabetes Mellitus, Type 2 by Instituto Nacional de Ciencias Medicas y Nutricion Salvador Zubiran that are under way reach primary completion within a year, 0 of them phase 3. Phase 3 first, then by date:
| Study | Primary completion |
|---|---|
| NCT06163248Instituto Nacional de Ciencias Medicas y Nutricion Salvador ZubiranChrono Nutrition and Insulin Resistance in Diabetes | 2027-04-01 |
| NCT07760883Instituto Nacional de Ciencias Medicas y Nutricion Salvador ZubiranMetformin Effects According to SLC16A11 Carrier Status | 2027-07 |
Among the 10 studies in Diabetes Mellitus, Type 2 by Instituto Nacional de Ciencias Medicas y Nutricion Salvador Zubiran, from their registry updates:
This prospective observational study will evaluate whether the SLC16A11 risk variant influences the response to metformin in adults with type 2 diabetes. Participants will be classified as carriers or noncarriers and followed for 6 months while receiving extended-release metformin titrated to the maximum tolerated dose, between 1,500 and 2,250 mg/day. The primary outcome is the change in glycated hemoglobin, with additional assessment of seven-point capillary glucose profiles, liver enzymes, visceral fat, lipid profile, and lactate concentrations. The study plans to include 154 participants to compare treatment response between both genetic groups and explore the potential value of a more personalized therapeutic approach.
Type 2 diabetes (T2D) is a major global health problem and is closely associated with obesity and an increased risk of microvascular and macrovascular complications. A risk haplotype located in the SLC16A11 gene has been associated with a higher susceptibility to T2D and may contribute substantially to the increased prevalence of the disease in the Mexican population. The SLC16A11 gene encodes a bidirectional solute transporter involved in the transport of monocarboxylates such as pyruvate and lactate. However, it is not yet clear whether this genetic variation influences the metabolic response to metformin.
This prospective, analytical, observational study aims to compare the effect of metformin treatment between adults with T2D who are carriers and noncarriers of the SLC16A11 risk variant. A total of 154 participants are planned to be included. Eligible participants will be men and women aged 18 to 65 years with T2D, glycated hemoglobin of 8% or lower, and an estimated glomerular filtration rate greater than 60 mL/min. Participants may be untreated or receiving metformin alone or as part of dual pharmacological therapy.
All participants will receive extended-release metformin with gradual dose titration according to tolerance. Treatment will begin with 750 mg at night during the first week, increase to 750 mg in the morning and 750 mg at night during the second week, and may reach 750 mg three times daily from the third week onward. The target dose will be the maximum tolerated dose, ranging from 1,500 to 2,250 mg/day. Telephone follow-up will be conducted during titration to assess tolerance and guide dose adjustment.
Participants will be followed for 6 months. The primary objective is to compare the change in glycated hemoglobin between carriers and noncarriers of the SLC16A11 risk variant. Additional outcomes will include the seven-point capillary glucose profile, liver enzymes, visceral fat, total cholesterol, triglycerides, HDL cholesterol, LDL cholesterol, and lactate concentrations.
The study is based on the hypothesis that carriers of the SLC16A11 risk variant will have a smaller reduction in glycated hemoglobin, estimated at 0.5 percentage points, after 6 months of metformin treatment compared with noncarriers. Understanding whether this genetic variant modifies the response to metformin may contribute to a more personalized therapeutic approach and improve knowledge of the mechanisms involved in metformin-mediated glucose regulation.
Participants receiving three glucose-lowering medications or insulin, as well as those who are pregnant, breastfeeding, have a body mass index of 45 kg/m² or higher, are participating in another study, or have selected chronic diseases such as HIV infection, cancer, or rheumatologic disease, will be excluded. Participants who cannot tolerate at least 1,500 mg/day of metformin, develop an estimated glomerular filtration rate below 30 mL/min during follow-up, or experience a serious adverse event related to metformin will be withdrawn from the study.
Adults aged 18 to 65 years with type 2 diabetes and glycated hemoglobin (HbA1c) ≤8%. Participants may be treatment-naïve, receiving metformin monotherapy, or receiving dual glucose-lowering therapy, and must have an estimated glomerular filtration rate (eGFR) >60 mL/min.
Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.
Exclusion Criteria:
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
GFR (glomerular filtration rate) is how much blood the kidneys filter each minute. It is usually estimated from a blood test — eGFR, by formulas such as CKD-EPI or MDRD — and some studies ask for it to be measured directly instead. Usually given in mL/min/1.73 m².
Check the method, the units and the minimum the study states. A value of 90 or above is in the normal-or-high range, but kidney damage can show in other tests too.
A blood test of average blood sugar over the past two to three months, given as a percentage or in mmol/mol. 6.5% (48 mmol/mol) or more is the usual threshold for diabetes, normally confirmed by a second test.
The human immunodeficiency virus, which weakens the immune system.
Many studies now accept people whose HIV is controlled on treatment, judged by the viral load and the CD4 count. Check the limits this study sets.
Weight in kilograms divided by height in metres squared. Example: 70 kg and 1.75 m gives 70 ÷ (1.75 × 1.75) ≈ 22.9.
What counts as overweight or obesity differs between countries (some use lower cut-offs), so go by the range the study states.
GFR and eGFR (kidney filtering)
GFR (glomerular filtration rate) is how much blood the kidneys filter each minute. It is usually estimated from a blood test — eGFR, by formulas such as CKD-EPI or MDRD — and some studies ask for it to be measured directly instead. Usually given in mL/min/1.73 m².
Check the method, the units and the minimum the study states. A value of 90 or above is in the normal-or-high range, but kidney damage can show in other tests too.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
HbA1c
A blood test of average blood sugar over the past two to three months, given as a percentage or in mmol/mol. 6.5% (48 mmol/mol) or more is the usual threshold for diabetes, normally confirmed by a second test.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
HIV
The human immunodeficiency virus, which weakens the immune system.
Many studies now accept people whose HIV is controlled on treatment, judged by the viral load and the CD4 count. Check the limits this study sets.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
BMI (body mass index)
Weight in kilograms divided by height in metres squared. Example: 70 kg and 1.75 m gives 70 ÷ (1.75 × 1.75) ≈ 22.9.
What counts as overweight or obesity differs between countries (some use lower cut-offs), so go by the range the study states.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Individuals with type 2 diabetes who carry the SLC16A11 risk variant and receive metformin treatment as part of their clinical management.
Individuals with type 2 diabetes who do not carry the SLC16A11 risk variant and receive metformin treatment as part of their clinical management.
Change in Glycated Hemoglobin (HbA1c)
Change in glycated hemoglobin (HbA1c), expressed as percentage points, from baseline to Week 12 and Week 24. Changes will be compared between participants with type 2 diabetes who are carriers and non-carriers of the SLC16A11 risk variant.
Time frame: Baseline, Week 12, and Week 24
Change in Fasting Plasma Glucose
Change in fasting plasma glucose concentration, measured in mg/dL, from baseline to Week 12 and Week 24. Changes will be compared between participants with type 2 diabetes who are carriers and noncarriers of the SLC16A11 risk variant.
Time frame: Baseline, Week 12, and Week 24
Change in Seven-Point Capillary Glucose Profile
Change in capillary glucose concentrations, measured in mg/dL, using a seven-point glucose profile: fasting, 2 hours after breakfast, before lunch, 2 hours after lunch, before dinner, 2 hours after dinner, and at bedtime. Results will be compared between SLC16A11 risk variant carriers and noncarriers.
Time frame: Baseline and Week 24
Change in Alanine Aminotransferase (ALT)
Change in serum alanine aminotransferase concentration, measured in U/L, from baseline to Week 12 and Week 24.
Time frame: Baseline, Week 12, and Week 24
Change in Aspartate Aminotransferase (AST)
Change in serum aspartate aminotransferase concentration, measured in U/L, from baseline to Week 12 and Week 24.
Time frame: Baseline, Week 12, and Week 24
Change in Gamma-Glutamyl Transferase (GGT)
Change in serum gamma-glutamyl transferase concentration, measured in U/L, from baseline to Week 12 and Week 24.
Time frame: Baseline, Week 12, and Week 24
Change in Total Cholesterol
Change in serum total cholesterol concentration, measured in mg/dL, from baseline to Week 12 and Week 24.
Time frame: Baseline, Week 12, and Week 24
Change in High-Density Lipoprotein Cholesterol
Change in serum high-density lipoprotein cholesterol concentration, measured in mg/dL, from baseline to Week 12 and Week 24.
Time frame: Baseline, Week 12, and Week 24
Change in Triglycerides
Change in serum triglyceride concentration, measured in mg/dL, from baseline to Week 12 and Week 24.
Time frame: Baseline, Week 12, and Week 24
Change in Low-Density Lipoprotein Cholesterol
Change in serum low-density lipoprotein cholesterol concentration, measured in mg/dL, from baseline to Week 12 and Week 24.
Time frame: Baseline, Week 12, and Week 24
Change in Apolipoprotein B
Change in serum apolipoprotein B concentration from baseline to Week 24.
Time frame: Baseline and Week 24
Change in Blood Lactate Concentration
Change in blood lactate concentration, measured in mmol/L, from baseline to Week 12 and Week 24. Changes will be compared between carriers and noncarriers of the SLC16A11 risk variant.
Time frame: Baseline, Week 12, and Week 24
Change in Visceral Fat Mass
Change in visceral fat mass, measured by dual-energy X-ray absorptiometry, from baseline to Week 24. Results will be expressed in grams and compared between SLC16A11 risk variant carriers and noncarriers.
Time frame: Baseline and Week 24
Eligibility is decided by the study team. Share this record with your doctor or contact the team directly.
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