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"Effect of restriction of calories in diet on cardio-metabolic risk factors among women with prediabetes in a northern district, Kerala

Effects of calorie restriction (CR) on biochemical (glycemic and lipid profile) and anthropometric parameters among women with isolated impaired fasting glucose in a northern district of Kerala

Status
Active, not recruiting
Phases
Phase 2
Study type
Interventional
Source
CTRI
Registry ID
CTRI/2022/07/043755
Enrollment
490
Registered
2022-07-06
Start date
Unknown
Completion date
Unknown
Last updated
2022-08-02

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

Conditions

Health Condition 1: E119- Type 2 diabetes mellitus without complications

Interventions

Intervention1: Carbohydrated limited and fat restricted diet: Calorie restriction on prediabetes females for a period of one year

Sponsors

Central University of Kerala
Lead Sponsor

Eligibility

Inclusion criteria

Inclusion criteria: 1) Women aged 30-60 years; 2) overweight or obese (waist circumference >=80 cm);22 3) no prior history of diabetes; 4) not taking any glucose-lowering medications; 5) no prior history of gestational diabetes mellitus (GDM); 6) able to read, write and speak Malayalam, the local language; 7) consents to participate in the trial; 8) diagnosed with i-IFG (fasting plasma glucose [FPG] 5.6-6.9 mmol/l and 2-hr plasma glucose [2-hr PG] <7.8 mmol/l) on a 2-hr oral glucose tolerance test (OGTT).

Exclusion criteria

Exclusion criteria: Those who does not meet the inclusion criteria is excluded from the studies

Design outcomes

Primary

MeasureTime frame
The primary outcome of the study is the change in fasting plasma glucose â?¤ 7.0 mmol/l.Timepoint: Blood collection at baseline 1st month and 12 months to measure glycemic FBS

Secondary

MeasureTime frame
1) The Change in HbA1c,Total cholesterol, high-density lipoprotein (HDL), low-density lipoprotein (LDL), and body fat composition will be assesed . 2)The changes in anthropometric measures like weight, BMI, waist circumference and hip circumference will be assesedTimepoint: 1) Glycemic measures will be assesed at baseline and at 12 th month 2) Anthropometric measures will be measured at baseline , 3rd month, 6thmonth, 9th month and 12 month

Countries

India

Contacts

Public ContactBhagiaswari K

Central University of Kerala

dr.elezebethmathews@cukerala.ac.in8547593637

Outcome results

None listed

Source: CTRI (via WHO ICTRP) · Data processed: Feb 4, 2026