Modulation of Metabolic Parameters Among Obese Diabetic Individuals Through a Gluten-Free Diet
Trial Snapshot
- Phase
- Not Applicable
- Status
- Completed
- Sponsor
- Enrollment
- 108
- Locations
- 1
- Primary Endpoint
- Assessment of Lipid Profile (mg/dL)
Study Overview
Brief Summary
This study benefits the community by highlighting the potential of a gluten-free diet as a non-pharmacological, effective approach to managing obesity and type 2 diabetes. By demonstrating significant improvements in weight, blood sugar, lipid levels, and liver function, it supports dietary modification as a practical approach to enhancing metabolic health. The findings can inform public health initiatives, raise community awareness about the role of nutrition in disease management, and promote personalized dietary interventions, ultimately contributing to better prevention and control of chronic metabolic conditions.
Detailed Description
2.1. The study received ethical approval from the Institute Research Ethics Board (IREB), University of Lahore (UOL/IREB/25/09/0008). Informed consent was obtained from all participants, who were fully briefed on the study's purpose, procedures, risks, and benefits, with the option to ask questions and withdraw at any time.
2.2. Study design The research trial, a randomized controlled trial (RCT), was carried out at the Dilawar Hussain Foundation, Diabetes Management Center, Lahore, Pakistan.
An intervention with a tailored gluten-free diet of 1800 kcal/day was planned. 2.3. Methods of data collection A total of 115 volunteers who met the inclusion criteria were recruited into the study. Seven participants left the study due to personal issues; a total of 108 patients left, which were divided into two equal groups (n=54 in each group).
Participants were randomly allocated to two study groups. Group T1 received a standard diet, whereas Group T2 received a gluten-free diet for 12 weeks. An 1800 kcal/day diet was nutritionally comparable, 50-55% of calories were from carbohydrates, 15-20% protein, and 25-30% fat. Fiber in the form of fruits, vegetables, legumes, and the right grains. The gluten-free variant omitted all sources of wheat, rye, and barley and thus was the ideal option for those needing a gluten-free diet. Follow-up sessions on alternate days were used to guarantee compliance throughout the intervention period, where dietary adherence was checked and reinforced. At the end of week 12th, biochemical tests were performed for all the subjects. The post-interventional measurements between the two groups were then compared to assess the metabolic effects of the gluten-free diet. This comparison was used to test the main hypothesis of the study.
2.4. Parameters for assessment The final dataset comprised anthropometric data: weight, height, body mass index (BMI), and waist circumference, 24-hour dietary recall, as outlined. In addition, fasting glucose level, Homeostatic Model Assessment for Insulin Resistance (HOMA-IR), systolic and diastolic blood pressure, and lipid profiles in serum (LDL, HDL, and total cholesterol) were measured using the same procedure.
Study Design
- Study Type
- Interventional
- Allocation
- Randomized
- Intervention Model
- Parallel
- Primary Purpose
- Supportive Care
- Masking
- Single (Participant)
Eligibility Criteria
- Ages
- 30 Years to 55 Years (Adult)
- Sex
- All
- Accepts Healthy Volunteers
- No
Inclusion Criteria
- •Patients who were obese diabetic adults of both genders, aged 30 to 55 years,
- •body mass index (BMI) > 25 kg/m²,
- •fasting glucose level > 135 mg/dL,
- •elevated parameters of lipid profile,
- •blood pressure > 135/85 mmHg,
- •Insulin Resistance (HOMA-IR) > 2.57
Exclusion Criteria
- •Patients with a diagnosis of celiac disease,
- •irritable bowel syndrome,
- •some cancers,
- •genetic illnesses,
- •respiratory illnesses, and psychiatric illnesses
Arms & Interventions
Treatment Group T2: Conventional treatment + Gluten-free diet 1800 Kcal/day
Group T2 received a gluten-free diet for 12 weeks
Intervention: gluten free diet (Other)
Control group (T1): Conventional treatment + Standard Diet
Group T1 received a standard diet, 1800 kcal/day for 12 weeks
Intervention: No intervention (Other)
Outcomes
Primary Outcomes
Assessment of Lipid Profile (mg/dL)
Time Frame: 12 Weeks
Blood samples for baseline and follow-up tests were collected in EDTA-treated tubes to assess hematological parameters. Total cholesterol (TC), triglycerides (TG), and HDL levels were measured using an enzymatic colorimetric method, whereas LDL-C concentration was checked with the help of a formula. The following equation was used to calculate very low-density lipoprotein cholesterol (VLDL). VLDL - c (mg∕dL) = TG∕5 LDL = Total cholesterol - (HDL + VLDL)
Anthropometric measurement
Time Frame: 12 weeks
Baseline anthropometric measurements, including weight, height, BMI, and waist circumference, were recorded following standard clinical procedures. Weight was measured with a calibrated electronic scale while subjects wore light clothing and were barefoot. Height was measured using a calibrated stadiometer with subjects standing erect and barefoot. BMI was calculated as weight (kg) divided by height squared (m²). Waist circumference was measured with a non-elastic tape placed midway between the lowest rib and iliac crest, ensuring the tape touched the skin without compressing it.
24-hour dietary recall method
Time Frame: 12 WEEKS
The 24-hour dietary recall method was used to assess participants' intake through structured interviews. A multi-pass approach ensured detailed and accurate reporting of food, portion sizes, and preparation methods. Recalls on non-consecutive days captured dietary variation, and data were analyzed using validated tools to estimate nutrient intake.
Secondary Outcomes
- Assessment of liver function (U/L)(12 Weeks)
- HOMA-IR(12 Weeks)
Investigators
Sana Noreen
Assistant Professor
University of Lahore