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Impact of Hypocaloric Diet on Clinical outcome and Gut Microbiota in Obese Patients with type 2Diabetes : A Pilot Study

Impact of Hypocaloric Diet on Clinical outcome and Gut Microbiota in Obese Patients with type 2Diabetes : A Pilot Study

Status
Unknown
Phases
Phase 3
Study type
Interventional
Source
TCTR
Registry ID
TCTR20240831002
Enrollment
20
Registered
2024-08-31
Start date
2024-03-06
Completion date
Unknown
Last updated
2026-08-03

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Type 2 diabetes with Obesity Gut Microbiota Type 2 diabetes Obesity Gut Microbiota Hypocaloric diet

Interventions

Participants received a 6-week hypocaloric diet ,followed by a 6-week weight maintenance period with a caloric intake of 1500-1800 kcal/day.,Participants received a normal diet of 1500-200 kcal/day th
Experimental Behavioral,No Intervention No treatment
Hypocaloric diet ,Control

Sponsors

Chulalongkorn University
Lead Sponsor
The Endocrine Society of Thailand
Collaborator

Eligibility

Sex/Gender
All
Age
30 Years to 60 Years

Inclusion criteria

Inclusion criteria: 1.Diagnosed with type 2 diabetes within the previous 10 years 2.Body mass index more than 25 kg/m2 3.Glycated hemoglobin level between 6.5 and 10%

Exclusion criteria

Exclusion criteria: 1.Use of steroids 2.Previous use of insulin 3.Previous treatment with a glucagon-like peptide-1 receptor agonist in the past 3 months 4.Serum creatinine more than 1.5 ng/mL 5.Serum alanine aminotransferase more than 2.5 fold above the upper limit of the reference range. 6.Diagnosed with Inflammatory bowel disease 7.History of metabolic or bariatric surgery 8.Previous treatment with probiotics in the past 3 months 9.History of weight change of more than 5% in the past 3 months

Design outcomes

Primary

MeasureTime frame
Metabolic Parameters 0,6 and 12 week Blood sample

Secondary

MeasureTime frame
Change of gut microbiota 0,6 and 12 week Fecal collection

Countries

Thailand

Contacts

Public ContactMongkontida Umphonsathien

Police General Hospital

muijai@hotmail.com66817217762

Outcome results

None listed

Source: TCTR (via WHO ICTRP) · Data processed: Aug 9, 2026